FDA import alert red lists: firms subject to detention without physical examination
Which foreign manufacturers, shippers and growers are on an FDA import alert red list, meaning every shipment from them is detained without physical examination (DWPE) at the US border. Each record is one firm on one import alert, with the firm name and address as FDA prints it, the country, the date FDA published the listing, and the product codes and product descriptions it covers. Answers 'is my supplier on an FDA import alert', 'is [firm] on the red list for import alert 66-41', 'why was my shipment detained without examination', 'which firms are on the FDA red list for undeclared pharmaceutical ingredients in supplements', and 'how do I check a Chinese manufacturer before ordering'. FDA publishes 153 separate import alerts as individual current-state pages with no cross-alert firm index, so answering 'is this firm flagged anywhere' means opening 153 pages; and firms are removed from red lists on petition with no record of the removal published at all, so an assistant answering from memory names firms that were delisted years ago.
Records424
Sources6
Verified2026-08-06
Review by2026-10-05
LicenceFacts extracted from FDA's freely published import alert pages on accessdata.fda.gov. US government work; firm names, addresses, product codes, publication dates and FDA's stated reasons are facts and not copyrightable. Each record links back to the import alert page it was read from. Note the disclaimer FDA prints on every alert and which every record page should carry: 'This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.'
The data
| Firm | Import alert | Import alert name | Country | Address | Date published | Product code | Product | FDA notes |
|---|---|---|---|---|---|---|---|---|
| World Pharmacy, Inc. (Mr. Roger Pemberton) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ANTIGUA & BARBUDA | Hodges Bay , St. John (West Indies), ANTIGUA & BARBUDA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 ;The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| MOLECULAR DYNAMICS SAS | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | ARGENTINA | Malabia 1177 , Buenos Aires, ARGENTINA | 03/12/2024 | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | XHUM Monarch Sexual Enrichment Supplement | XHUM Monarch Sexual Enrichment Supplement | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. |
| Biomedical Holding AVV | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ARUBA | Unknown , Unknown, ARUBA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 |
| Crowded Planet c/o Richard Hughes | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | AUSTRALIA | P.O. Box 920 , Wollongong (East), New South Wales AUSTRALIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 |
| Biopharm Australia Pty. Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 111 Bronte Road , Bondi Junction, NSW AUSTRALIA | 03/31/2026 | 55 Y - - 99 Pharmaceutic Necessities and Containers, N.E.C. | 66 Q - - 10 Pentosan Polysulfate Sodium (Uricosuric) | Cartrophen Equine Forte | Cartrophen Equine Forte | |
| Ceva Animal Health Pty Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 11 Moores Rd , Glenorie, New South Wales AUSTRALIA | 09/09/2015 | 64 R J Y 99 Hormone N.E.C., Animal (Food Producing) - Non-Rx/Single Ingredient, NEC | REGULIN IMPLANT FOR EWES/50 DOSES | |
| Prestige Blending | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 59 Lahr's Rd , Ormeau, Queensland AUSTRALIA | 04/28/2021 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 70 E - - 11 Amino Acid | 70 E - - 11 Amino Acid | 70 E - - 11 Amino Acid | 70 E - - 11 Amino Acid | Race Condition | Liquid Gold | Performance Horse Muscle Matrix | ProJoint | Race Condition | Performance Horse Muscle Matrix | Liquid Gold | ProJoint | ProJoint | Race Condition | Performance Horse Muscle Matrix | Liquid Gold | |
| Value Plus Animal Health Care Pr | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 124 Toongabbie Rd , Girraween, New South Wales AUSTRALIA | 10/16/2023 | 60 Z - - 30 Praziquantel/Pyrantel Pamoate combination (Antiparasitic) | 62 L - - 47 Ivermectin (Anti-Protozoal, A-Leishmanial, Anti-Malarial) | Canine All Wormer | Valuheart | |
| Zoetis Australia Pty Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | Level 6, 5 Rider Boulevard , Rhodes, AUSTRALIA | 12/12/2023 | 60 - R - -- Human and Animal Drugs, Animal (Non-Food Producing) Rx/Comb Ingredient | Simparica TRIO | Products subject to DWPE include those marketed for dogs weighing 2.6kg to 60kg. |
| DurusPharma | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | Peel Street 4 , Grand Bahamas , Freeport, City of Freeport BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 |
| InterPharm Inc (d/b/a International Pharmacy) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | Po Box N-3036 , Nassau, New Providence BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | |
| Juan Martinez Minitraders | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P.O. Box N-121 , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | |
| Medicine Club of America Inc (International Pharmacy) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P O Box N-3036 , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | |
| Minitraders (Mr. Juan Martinez) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P.O. Box N-121 , Nassau , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Northam Medication Service | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P O Box N-7108 , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | |
| Universal Trading | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | Harbour Building , Suite 6-1; Grand Bahama Island , Freeport, City of Freeport BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 |
| Laboratoires Ndv | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | BELGIUM | B 1930 Zaventen , Brixtonlaan, BELGIUM | 04/13/2012 | 53 L - - 99 Other Skin Care Preparations, N.E.C. | Nelly De Vust Slimming Oil | Staphyloccus xylosus |
| E Claes | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| M Bourquin | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| Margaret Eden | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | B 82 , Amerikalei 159 , Antwerp, Antwerp BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| N Clan | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| S Kessler | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | B 82 , Amerikalei 159 , Antwerp, Antwerp BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| Zita Tros | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| GHO AHK SPRL | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BELGIUM | Boulevard Edmond Machte , Brussels, BELGIUM | 09/30/2025 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 66 X - - 99 Homeopathic N.E.C. | 70 E - - 99 Additives, N.E.C. | 70 M - - 02 Horse Mixed Feed Ration | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | |
| Medichin N.V. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BELGIUM | Grote Baan 97/5 , Hasselt, Limburg BELGIUM | 11/29/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Four Yellows | VI Formula | Nerve Restore | Pro-K | Hot Feet USA | Sinking | White Tiger | Tendon | Lady Plus Formula | Desert Fire | Bleeder USA | Bleeder USA | Four Yellows | White Tiger | Pro-K | Desert Fire | VI Formula | Lady Plus Formula | Hot Feet USA | Nerve Restore | Tendon | Sinking | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 |
| Reprobiol Sprl | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BELGIUM | Lorce 1 , Lorce, Liege BELGIUM | 12/10/2014 | 68 L - - 99 Disposable/Sigle Use Devices, NEC (Nonhuman) | 68 M - - 03 Cages, including oxygen cages (Nonhuman) | 68 M - - 07 Hematology Analyzer (Nonhuman) | 68 Z - - 99 Animal Medical Devices, NEC | STIMUFOL - Follicle Stimulating Hormone (FSH) | STIMUFOL - Follicle Stimulating Hormone (FSH) | STIMUFOL - Follicle Stimulating Hormone (FSH) | STIMUFOL - Follicle Stimulating Hormone (FSH) | |
| Michelle Gleneuine | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | BRAZIL | Av. Canal Marapendi No , 4100/ 1105 BL1 , Rio de Janeiro, RJ BRAZIL | 05/11/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | PEB One and PEB Two Capsules (Brand Renutryent) Dietary Supplement | PEB One and PEB Two Capsules (Brand Renutryent) Dietary Supplement | Product contains undeclared Fenproporex HCL and Chlordiazepoxide HCL. | Product contains undeclared Fenproporex HCL and Chlordiazepoxide HCL. |
| Lavizoo-Lab Vitamins and Zootechnics | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BRAZIL | Rua Jose Antonio Da Silva Junior 900 , Distr. Industrial Cep, Distr. Industrial CEP BRAZIL | 07/31/2024 | 63 B - - 35 Clenbuterol (Bronchodilator) | 63 B - - 99 Bronchodilator N.E.C. | Clenbuterol | Clenbuterol | |
| EFES Corporation | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BRITISH VIRGIN ISLANDS | Abbot Building 2nd floor , P O Box 933 , Road Town, Tortola BRITISH VIRGIN ISLANDS | 09/10/2009 | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | 8/9/1993 | 8/9/1993 | 8/9/1993 | 8/9/1993 | 8/9/1993 | 8/9/1993 | 8/9/1993 |
| Apollo Nutraceuticals Inc | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 20 Graniteridge Rd , Concord, Ontario CANADA | 03/14/2011 | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | Daily Skin Facial Scrub | 601(a) Staphylococcus Hominis |
| Demco Manufacturing Inc | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 5485 Ramsay , Saint-Hubert, QC CANADA | 09/18/2009 | 53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Crayon Face Paint Markers | Crayon Face Paint Markers;8/9/07 | Crayon Face Paint Markers;8/9/07 | Crayon Face Paint Markers;8/9/07 | 601(a);Yeast/mold;viable gram positive rods ; 8/9/07 | 601(a);Yeast/mold;viable gram positive rods | 601(a); yeast/mold; viable gram postive rods | 601(a); Yeast/mold; viable gram positive rods |
| Estee Lauder | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 217 Idema Rd , Markham, ON CANADA | 07/20/2011 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | MAC Double Feature 4 Tealdrop (WN)/Original Ochre (WN) Eyeshadow | 601 (a) Sphingomonas; paucimobilis;shewanella putrefaciens |
| Evergreen Consumer Brands Ulc | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 100 Delta Park Blvd , Brampton, Ontario CANADA | 01/13/2015 | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | Spa Haus Aqua Bold Shower Gel for Men | Problem(s); Various Gram-positive cocci and Gram-negative rods; including opportunistic pathogens Note; 601(a) Opportunistic pathogens; Acinetobacter lwoffii and Sphingomonas paucimobilis |
| Golden Moor | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 38 Indsutiral , Casselman, Ontario CANADA | 02/16/2011 | 53 B D - 99 Other Bath Preparations, N.E.C., Liquid, Lotion | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | Bain de Boue (Mud Bath) | Natural Face Mask | 601(a) Enteroccus faecalis Pseudmonas putida Stenotrophomonas maltophilia Enterobacter amnigenus Acinetobacter radioresistens | Pseudomonas Fluorescens |
| ITN Food | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 40 Commander Boulevard , Toronto, Ontario CANADA | 01/13/2015 | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Ubtan Powder | Mold Gram-negative organisms; Gram-positive organisms; Gram-positive cocci; |
| Laboratoires Bio Botanical, Inc. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 22200 Aut Transcanadienne , Baie-d'Urfe, Quebec CANADA | 09/18/2009 | 53 A D - 01 Baby Shampoo (Baby Products), Liquid, Lotion | 53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | Lil Goat's Milk Shampoo and Body Wash | Li'l Goat's Moisturing Lotion | Shampoo (Clearly Natural Brand) | 601 (a) Enterobacter gergoviae | Milk 601(a) gram negative rods and Enterobacter gergoviae; 6/15/2010 | 601(a)/Pseudomonas, aeruginosa; 6/18/2003 |
| Les Productions Pupazzo | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 788 Avenue Greene , Montreal, QUEBEC CANADA | 01/25/2013 | 53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products) | Pupazzo Soothing face & Body Milk (Delicate Fragrance) | 601(a) P. aeruginosa |
| Mistura Beauty | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 5350 Canotek Rd Unit 7 , Gloucester, ON CANADA | 08/27/2015 | 53 G - - 02 Face Powders (Makeup Preparations, not for Eyes) | 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | Mineral Based Powder Six in One Cosmetic Powder (Eliminates need for foundation; concealer; blush; bronzer; lipstick; & eye shadow; 6 in 1);NOTE: ;Problem(s); Staphylococcus warneri ; Staphylococcus pasteuri;9/2/2015 | Mineral Based Powder Six in One Cosmetic Powder (Eliminates need for foundation; concealer; blush; bronzer; lipstick; & eye shadow; 6 in 1); NOTE: ;Problem(s); Staphylococcus warneri ; Staphylococcus pasteuri; 9/2/2015 | Mineral Based Powder Six in One Cosmetic Powder (Eliminates need for foundation; concealer; blush; bronzer; lipstick; & eye shadow; 6 in 1); NOTE: ;Problem(s); Staphylococcus warneri ; Staphylococcus pasteuri;9/2/2015 | |
| Neuco | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CANADA | 1899 Lionel Bertrand , Boisbriand, QUEBEC CANADA | 12/09/2013 | 53 A - - 01 Baby Shampoo (Baby Products) | Green Babies Tearless Baby Me Shampoo & Wash | 601(a) Staphylococcus spp. |
| Nugale Pharmaceutical Inc. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CANADA | 41 Pullman Crt , Scarborough, Ontario CANADA | 04/14/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Slimquick Green Coffee Bean Softgel | Slimquick Green Coffee Bean Softgel | FDA analysis found Sibutramine; N-desmethyl Sibutramine; and Phenolphthalein in product. | FDA analysis found Sibutramine; N-desmethyl Sibutramine; and Phenolphthalein in product. |
| PNP Pharmaceuticals Inc. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CANADA | 9388 North Fraser Cres , Burnaby, British Columbia CANADA | 05/26/2020 | 54 A - - 99 Vitamin, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | U-Dream Lite Herbal Blend | U-Dream Lite Herbal Blend | U-Dream Lite Herbal Blend | FDA laboratory analysis confirmed product contains undeclared Zopiclone. Zopiclone is a Schedule IV controlled substance. | FDA laboratory analysis confirmed product contains undeclared Zopiclone. Zopiclone is a Schedule IV controlled substance. | FDA laboratory analysis confirmed product contains undeclared Zopiclone. Zopiclone is a Schedule IV controlled substance. |
| BEDESSEE IMPORTS LTD | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 2 Golden Gate Crt , Scarborough, Ontario CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 |
| Brash, Dolores | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | P.O. Box 2361 , Sardis Station Main , Chilliwack, BC CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 |
| Canada Drugs | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 24 Terracon Pl. , Winnipeg, MB CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/25/2006 ; Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. |
| Canada Rx Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 800 15355 24th Ave Ste. 551 , Surrey, British Columbia CANADA | 03/14/2017 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | |
| De La Web Multimedia Exposicion, Inc. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 48 Par-la-Ville Road, Suite 812 , Hamilton, ON CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | All prescription drugs; 9/15/2000 | |
| ELIE PHARMACY | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 1 Main St East , Elie, MB CANADA | 04/14/2025 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Hunters Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 3019 Tecumseh St E , Windsor, ON CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 6/24/2002 | All prescription drugs; 6/24/2002 | All prescription drugs; 6/24/2002 | All prescription drugs; 6/24/2002 | All prescription drugs; 6/24/2002 | All prescription drugs; 6/24/2002 | All prescription drugs; 6/24/2002 | All prescription drugs; 6/24/2002 |
| Mediplan Healthcare Consulting | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 561 Sixth Ave Nw , Minnedosa, MB CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Rx drugs | 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and |
| MEDIPLAN PHARMACY | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 115 MAIN STREET SOUTH , Minnedosa, MB CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | |
| NorthWestPharmacy.com | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | Po Box 56056 Rpo Valley Centre , Langley, British Columbia CANADA | 03/14/2017 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | |
| Optimum Compounding Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 10171 Yonge St , Richmond Hill, Ontario CANADA | 09/10/2009 | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 B - - 99 Stimulant N.E.C. | Sildenafil Citrate 50mg oral (sublingual route of administration) | Sildenafil Citrate 50mg oral (sublingual route of administration) | 4/22/2003 | 4/22/2003 |
| PARKWAY PHARMACY | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 1123 Empress St , Winnipeg, Manitoba CANADA | 01/31/2025 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Point Douglas Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 885 Main St , Winnipeg, Manitoba CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All preseciption drugs 11/25/2001 | All preseciption drugs 11/25/2001 | All preseciption drugs 11/25/2001 | All preseciption drugs 11/25/2001 | All preseciption drugs 11/25/2001 | All preseciption drugs 11/25/2001 | All preseciption drugs 11/25/2001 | All preseciption drugs 11/25/2001 | |
| PrescriptionPoint | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | Suite 537 , 102-17750 56 Ave , Surrey, British Columbia CANADA | 03/14/2017 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | |
| Rx.North.com | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | PO Box 1324 Stn Main , Winnipeg, Manitoba CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | |
| RxNorth.com | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 115 Main St. South , Minnedosa, MB CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | All Rx drugs - 11/25/2001 Revised to include additional firm names - 11/29/2006 aka Mediplan Global Health aka Mediplan Health Pharmacy aka Canam Pharmacy aka Mediplan Health aka Mediplan Prescription Plus Pharmacy Websites: and | |
| Sameday (Canada Drugs) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 225 Haggart Ave , Winnipeg, MB CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/25/2006; Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. |
| Sameday (Day And Ross) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 225 Haggart Ave , Winnipeg, MB CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/25/2006 ;Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. | All prescription drugs - 8/25/2006 Since May 30, 2006, Customs Border Patrol detained approximately 75 entries of imported prescription drugs invoiced as �med supply� consigned to individuals in the U.S. from the above three shippers. It was determined that the drugs were worth much more than their invoiced value of $1. These drugs are foreign manufactured and are not FDA approved for sale in the U.S. CDER is not aware of any substantial scientific evidence that these drugs are generally recognized as safe and effective for the conditions recommended in their labeling. |
| Serono Canada | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 5915 Airport Rd, Suite 810 , Mississauga, ON CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | Beta-interferon (Alternate names - Rebif, R-FRONE); 12/22/1994 | |
| Target Zone Training | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CANADA | 453 Toynevale Rd , Pickering, Ontario CANADA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 |
| Adored Beast Apothecary | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 129 Gerrish St , Windsor, Nova Scotia CANADA | 08/24/2016 | 26 - - - -- Vegetable Oils | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 68 - - - -- Animal Devices and Diagnostic Products | All Products | All Products | All Products | |
| Alcon Canada Inc | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 2665 Meadowpine Blvd , Mississauga, Ontario CANADA | 05/10/2017 | 56 D - - 40 Neomycin (Aminoglycosides) | 56 D - - 49 Neomycin, N.E.C. (Aminoglycosides) | 56 F - - 30 Polymyxin B Sulfate (Peptides) | 64 L - - 19 Dexamethasone (Glucocorticoid) | Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension | Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension | Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension | Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension | |
| Boehringer Ingelheim Canada | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 5180 South Service Rd , Burlington, Ontario CANADA | 09/06/2024 | 60 L - - 99 Analgesic, N.E.C. | 65 V - - 99 Sedative N.E.C. | Sedivet (Romifidine hydrochloride) | Sedivet (Romifidine hydrochloride) | |
| Groupe Parima Inc. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 4450 Cousens St , Saint-Laurent, Quebec CANADA | 07/05/2017 | 61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic) | 61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic) | Malaseb Flush 12 oz. | Malaseb Flush 4 oz. | |
| life spring mfg ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 312 Kennard Ave , North Vancouver, British Columbia CANADA | 07/19/2019 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Breathe Easy EquiPulmin | Breathe Easy EquiPulmin | |
| Mineral Medix Solutions Inc. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 100 Leek Cres Unit 12 , Richmond Hill, Ontario CANADA | 08/19/2020 | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 04 Foot Powders and Sprays (Skin Care Preparations) | 56 G - - 99 Antifungal N.E.C. | 60 L - - 03 Anilopam HCl (Analgesic) | 60 L - - 99 Analgesic, N.E.C. | 60 Z - - 99 Antiparasitic, N.E.C. | 61 H - - 99 Anti-Bacterial, N.E.C. | 62 B - - 14 Omega-3-Acid Ethyl Esters (Anti-Hyperlipidemic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 L - - 15 Bandages, Gauze pads, plain (Nonhuman) | 68 L - - 16 Bandages, Gauze pads, non-stick (Nonhuman) | 68 S - - 99 Animal Diagnostics, NEC | 68 Z - - 99 Animal Medical Devices, NEC | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | HOOF DOCTOR Lotion/Dressing (Birch Bark Extract) | 8/19/2020 |
| Natures Formulae Health Products Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 2130 Leckie Pl Suite 300 , Kelowna, British Columbia CANADA | 04/20/2018 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | NaturPet Joint Care | NaturPet D Wormer | NaturPet Life Flow | NaturPet Joint Care | NaturPet Life Flow | NaturPet D Wormer | |
| NaturPet Inc. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 300-2130 Leckie Place , Kelowna, British Columbia CANADA | 04/20/2018 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | NaturPet D Wormer | NaturPet Joint Care | NaturPet Life Flow | NaturPet D Wormer | NaturPet Joint Care | NaturPet Life Flow | |
| Nu Paradigm Animal Health Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 129 Fisher Ave , Cochrane, Alberta CANADA | 01/13/2020 | 65 T - - -- Scabicide | SULFUR/LIGNIN SULFONATE for Dogs | |
| Omega Alpha Pharmaceuticals | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 795 Pharmacy Ave , Scarborough, Ontario CANADA | 03/04/2020 | 54 A - - 99 Vitamin, N.E.C. | 54 C - - 13 L-Lysine (Protein) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | PROBIOTIC | L-LYSINE & CRANBERRY POWDER | PROBIOTIC | L-LYSINE & CRANBERRY POWDER | PROBIOTIC | FOOD BOOSTER | FOOD TOPPER | YUCCA REFILL | FOOD TOPPER | PROBIOTIC | YUCCA REFILL | FOOD BOOSTER | L-LYSINE & CRANBERRY POWDER | |
| The Nutraceutical Medicine Company Inc dba Purica | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CANADA | 6157 Scott Rd , Duncan, British Columbia CANADA | 09/18/2018 | 54 Y L - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C., Enrich Anml Fd | 66 V R - 99 Miscellaneous Patent Medicines, Etc., Animal (Non-Food Producing) Rx/Comb Ingredient | Recovery EQ for horses | Recovery EQ for horses | |
| Beauty Vision Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Blk.c,bao Tong Ind.dist.tong Mei Village , Gong Ming Town,bao An County, , Shenzhen, CN-44 CHINA | 06/23/2011 | 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | 53 G K - 06 Makeup Bases (Makeup Preparations, not for Eyes), Sticks | Eye Shadow and Lip-Gloss (Contained in Bratz Makeup Design Sketch Book) | Eye Shadow and Lip-Gloss (Contained in Bratz Makeup Design Sketch Book) | 601(a) Staphylococcus intermedius; Staphylococcu warneri; Gram Positive Coccus | 601(a) Staphylococcus intermedius; Staphylococcu warneri; Gram Positive Coccus |
| Elle Jewelry Corp | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | 37-3 Nong Gong Road Yiwu , Zhejiang, CHINA | 09/18/2009 | 53 C - - -- Eye Makeup Prep | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Lip.eye line pencil | lip/eye liner pencil; 3/31/03 | 601(c);CHRYSEOMONAS : LUTEOLA; PSEUDOMONAS : NOT SPECIATED;3/31/03 | CHRYSEOMONAS : LUTEOLA; PSEUDOMONAS : NOT SPECIATED; |
| FUJIAN ISHINE COSMETICS CO.,LTD | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Erji Road , Zhenghexian , Nanping, Fujian CHINA | 03/19/2015 | 53 C - - 02 Eyeliner (Eye Makeup Preparations) | LUV@KISS/ Multifunctional Eyeliner | Problem(s); Microbiological Contamination Note; Product (Glitter Eyeliner) presents a safety concern due to the presence of microorganisms in excess of 500 CFU/gram. |
| Hainan Fuwang Industrial Co., Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Room 9b , Beijing Bldg A6 Garden Financial; Haikou , Hainansheng, Hainan CHINA | 03/24/2017 | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | Peppermint Scrub | BACILLUS : PUMILUS; BACILLUS : NOT SPECIATED; |
| Her Maow Cosmetics | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Ind. Tong Hu , 6 Guanghe; Th Area Tonghuzhen , Huizhou, Guangdong CHINA | 06/06/2013 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye Shadow Hard Candy 10 Well Compact | Brow Powder Taupe | 601(a);Bacillus spp.;Lysinibacillus ssp;Staphylococcus lentus; Staphylococcus xylosus; Pseudomonas psedoalcaligenes; kocuria varians | 601(a); B.cereus/thuringiensis/mycoides;B.lentus;B pumilus; Brevibacillus choshinensis |
| Jinhua Aoshiya Cosmetics Co Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | # 1666 Shenli Rd Jinhua Econ & Tech , Jinhua, Zhejiang CHINA | 05/09/2023 | 53 G - - 10 Children Novelty Face Makeup Kits | LOL Surprise! Remix Cosmetic Set | Staphylococcus warneri, Staphylococcus epidermidis, Kocuria spp., Gram-positive rods, and elevated levels of bacteria were identified in the sample. |
| Jinhua Selead Biotechnology Co., Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | 4F, 5F, NO.1238 , Jinsha Street, Linjiang Industry Park, Wucheng District , Jinhua, Zhejiang CHINA | 07/12/2024 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Flawless Beauty Eyeshadow Palette | Sweet Beauty Eyeshadow Palette | BACILLUS : CEREUS; | BACILLUS : CEREUS; |
| Jinhua Yitong Biotechnology Co Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No 58 Xingpu Road Baima town Pujiang County , Jinhua City, Zhejiang CHINA | 08/23/2024 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | PH Dream Girl Face and Eyeshadow Palette | [Adulteration, Section 601(a)] Specifically, Bacillus cereus, as well as several other Bacillus and Paenibacillus species. Fungal colonies were also detected and identified as Microascus sp., Chaetomium sp., Coprinellus/Psyathyrella sp., Paecilomyces sp. and two unidentified fungal species. |
| Jinmei Co Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No 82 Luhu East Rd , Qingxi Town , Dongguan City, Guangdong CHINA | 05/05/2015 | 50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C. | Body Paint/Pigment | Problem(s); Gram Positive Rods Gram Negative Rods Endotoxins; 601(a) Contaminated with microorganisms |
| Johns Cosmetic | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Li Lang Da Dao , Shenzhen, CHINA | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | Multi-use Eye Shadow; 3/15/05 | Multi-use Eye Shadow; 3/15/05 | 601(a); gram positive and negative bacteria | CITROBACTER; STAPHYLOCOCCUS : AUREUS; | 601(a); gram pos and neg bacteria | CITROBACTER; STAPHYLOCOCCUS : AUREUS; |
| Maanshan Yingkai International Trading Co. Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Tangnan, Dangtu , Maanshan City, CHINA | 04/24/2017 | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | Day & Night False Eyelashes and Glue Set | Batta Lash False Eyelashes and Glue Set | 601(a); high aerobic plate count reported as Bacillus coagulans | BACILLUS : COAGULANS; | 601(a); high aerobic plate count reported as Bacillus coagulans | BACILLUS : COAGULANS; |
| NICE HARVEST PLASTIC ENTERPRISE | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | NO. 16 Putuoshan Road , Beilun District , Ningbo, CHINA | 01/25/2017 | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | Brows (eye cosmetic kit) | Bacillus spp. (a group of Bacillus species due to low discrimination) B. licheniformis | BACILLUS; |
| Ningbo Hiking Imp & Exp Co., Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Room 2209 , 139 Yaohank Street , Ningbo, CHINA | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | Le Le Make up set; 1/25/07 | Le Le Make-up Set; 1/25/07 | 601(a) | PSEUDOMONAS : AERUGINOSA; | 601(a) | PSEUDOMONAS : AERUGINOSA; |
| Ningbo Kangsheng Print Pack | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No. 19 Jinsi Road , Ningbo, CHINA | 07/27/2016 | 53 G - - 11 Children Novelty Body Paints | Tattoo Pens | Bacillus smithii; Bacillus simplex; Bacillus fortis; Paenibacillus glucanolyticus; Candida pelliculosa; were also identified. | BACILLUS : MEGATERIUM; ENTEROCOCCUS : CASSELIFLAVUS; BACILLUS : PUMILUS; |
| SanYuanSu Cosmetics Factory | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | 27344 District H International , Reade Center , Yiwu, ZheJiang CHINA | 02/03/2016 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Diamond Mascara | Problem: Achromobacter xylosoxidans | PSEUDOMONAS : PUTIDA; BACILLUS : LENTUS; |
| Shanghai Color Art Stationery Company Limited | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | 85 Xingchuansha Road , Loujing, Boashan , Qu Shanghai, CHINA | 09/30/2009 | 53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes) | Face and Body Paints | 601 (a) Yeast/Mold Gram Positive Rods High Aerobic Plates Counts 7/15/09 |
| Shenzhen Yada Cosmetics Co Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | 4/F 02 Bld Fuzhao Center Buxin Rd , Shenzhen, CHINA | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye Shadow; 7/14/03 | 601(c) | PSEUDOMONAS; CHRYSEOMONAS; |
| VEGAR COSMETICS | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | F 5 , No 12 Taian Rd; Xiangqiao , Chaozhou, Guangdong CHINA | 06/08/2018 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Simply Mascara | BREVIBACILLUS CHOSHINENSIS | BACILLUS : PUMILUS; BACILLUS : NOT LISTED, IDENTIFY IN REMARKS; |
| Xiamen Royal Bath Accessories Co | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No#5 Building,Pan Tu Ind.Estate , Xiamen Citychina, CHINA | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye Shadow | 601(a) high aerobic plate count identified as Stenotrophomonas maltophilia (Pseudomonas); 4/14/08 | PSEUDOMONAS : MALTOPHILIA; |
| XIAMEN ROYAL BATH ACCESSORIES CO.,LTD | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | # 2135 Yanshen Duan Huli Dadao , Zhongzhai Country Huli Xiamen China , Xiamen, CHINA | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye Shadow | 601(a) high aerobic plate count identified as Stenotrophomonas maltophilia (Pseudomonas); 4/14/08 | PSEUDOMONAS : MALTOPHILIA; |
| Yiwu City Ludanmei Cosmetics Co. Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Yidong Niansanli , NO. 15 Niansanli Jiedao WuyanbeiluZHEJIA , Jinhua, Zhejiang CHINA | 06/06/2013 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye Shadow | 601(a);Paenibacillus amylolyticus Paenibacillus polymyxa |
| Yiwu Mingyun Cosmetic Co Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No 98 Xiangyi Rd Yiting , Yiwu City, CHINA | 08/17/2016 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Triple Crown Baked Shadow Blue Hawaii (Eye Shadow) | Gram positive; coagulase negative cocci | BACILLUS : LICHENIFORMIS; ENTEROCOCCUS : FAECIUM; BACILLUS : THURINGIENSIS; BACILLUS : PUMILUS; |
| ZHEJIANG GOLDEN LOTUS IMPORT/EXP | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | Rm 2904 , NO 1107 Tianton; District, Nin , Yinshan, CHINA | 04/20/2023 | 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | Eye Shadow; Chameleon Metallic Eye Shadow; 9Holo Green Shadow | Elevated level of bacteria, yeasts, and molds. |
| ZHEJIANG MINGZHUANG COSMETICS CO.,LTD | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | 222#, CHANGFENG NORTH STREET , JINDONG ECONOMIC DEVELOPMENT ZONE , JINHUA CITY, Zhejiang CHINA | 02/03/2016 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Kleancolor Bowtux lash mascara | 601(a) Contaminated with microorganisms | BACILLUS : CEREUS; STAPHYLOCOCCUS : WARNERI; STAPHYLOCOCCUS : EPIDERMIDIS; |
| Zhejiang Pure Essential Cosmetic Co., Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No. 92 Qiuling Road , Economic Development Zone , Lanxi, Zhejiang CHINA | 05/26/2020 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 G - - 02 Face Powders (Makeup Preparations, not for Eyes) | 53 G - - 02 Face Powders (Makeup Preparations, not for Eyes) | 53 G - - 02 Face Powders (Makeup Preparations, not for Eyes) | 53 G - - 02 Face Powders (Makeup Preparations, not for Eyes) | 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | HIGHLIGHT & EYESHADOWS PALETTE | HIGHLIGHT & EYESHADOWS PALETTE | HIGHLIGHT & EYESHADOWS PALETTE | LAB-1102 A3O Flawless Setting Finishing loose Powder (Even Tone) | PERFECT FINISHING PRESSED POWDER | HIGHLIGHT & EYESHADOWS PALETTE | LAB-1101 A2O Flawless Setting Finishing loose Powder (Red No More) | PERFECT FINISHING PRESSED POWDER | Bacillus species, including B. cereus. | Bacillus species, including B. cereus. | Bacillus species, including B. cereus. | Gram-positive rods mostly, including Bacillus cereus. | Streptococcus mitis/Streptococcus oralis, sanguinis, salivarius ssp salivarius, mutans, and Gram positive cocci. | Bacillus species, including B. cereus. | Gram-positive rods mostly, including Bacillus cereus. | Streptococcus mitis/Streptococcus oralis, sanguinis, salivarius ssp salivarius, mutans, and Gram positive cocci. |
| Zhejiang Yasili Cosmetics Co., Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No. 163 Youyi West Rd , Yitingzhen Yiwu , Jinhua, Zhejiang CHINA | 09/18/2009 | 53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations) | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Eye Pencil; 3/1/05 | 3/1/05 | eye shadow; eye pencil; cream eye shadow; 3/1/05 | 601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram neg rods | ACINETOBACTER; PSEUDOMONAS; | 601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram neg rods | PSEUDOMONAS; ACINETOBACTER; | 601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram negative rods | PSEUDOMONAS; ACINETOBACTER; |
| Zhongshan Metro Cosmetics Ind Co Lt | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | No 1 Shunming St , Zhongshan City, CHINA | 09/18/2009 | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Cosmetic Sets; 3/31/03 | 601(c); multiple micro contamination; unidentified gram neg non-fermenters; Actinobacillus ureae; Shingomonas paucimobilis | ACINETOBACTER : JUNII; ACINETOBACTER : LWOFFI; ACTINOBACILLUS : NOT LISTED, IDENTIFY IN REMARKS; AGROBACTERIUM : RADIOBACTER; STAPHYLOCOCCUS : AURICULARIS; OCHROBACTRUM : ANTHROPI; PASTEURELLA : HAEMOLYTICA; PHOTOBACTERIUM; CHRYSEOMONAS : LUTEOLA; |
| Zhuhai Maxis Cosmetics Prod.Co. Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CHINA | 6e Nanxi Industry District #A2 , Qinshan, , Zhuhai City, Guangdong CHINA | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye Shadow Kit; 7/14/03 | 601(c); multiple micro contamination; Sphingomonas paucimobilis | ACINETOBACTER : JUNII; ACINETOBACTER : LWOFFI; PASTEURELLA : TREHALOSI; PASTEURELLA : HAEMOLYTICA; PASTEURELLA : MULTOCIDA; CHRYSEOMONAS : LUTEOLA; |
| BEIJING JIANYANG HEALTH PRODUCT CO., LTD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Liren Street , Beiging , Beijing, Beijing CHINA | 05/07/2015 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Super Shanghai Strong Testis Capsules "Dietary Supplement" | Super Shanghai Strong Testis Capsules "Dietary Supplement" | Super Shanghai Strong Testis Capsules "Dietary Supplement" | Product contains undeclared Sibutramine. | Product contains undeclared Sibutramine. | Product contains undeclared Sibutramine. |
| Beijing Kowloon Pharmaceutical Factory | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | No 1200 Diyang Bldg , Beijing, CHINA | 06/29/2015 | 54 C - - 02 L-Arginine (Protein) | 54 F - - 29 Yohimbe (Herbal & Botanicals, not Teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement) | 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement) | 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement) | 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement) | Product contains undeclared chemical "Hydroxycetildenafil" an analog of Sildenafil. | Product contains undeclared chemical "Hydroxycetildenafil" an analog of Sildenafil. | Product contains undeclared chemical "Hydroxycetildenafil" an analog of Sildenafil. | Product contains undeclared chemical "Hydroxycetildenafil" an analog of Sildenafil. |
| Casco Blu Qingdao | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | N3 P Rm , 901 Yishi Yijia Buildin No.6 , Qingdao, CHINA | 09/28/2016 | 31 K - - 02 Tea, Green | 54 F - - 28 Willowbark (Herbal & Botanicals, not Teas) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Green Tea/ White Willow Bark Extract | Green Tea/ White Willow Bark Extract | Green Tea/ White Willow Bark Extract | Green Tea/ White Willow Bark Extract | Sildenafil | OXYTETRACYCLINE; | Sildenafil | OXYTETRACYCLINE; | Sildenafil | OXYTETRACYCLINE; | Sildenafil | OXYTETRACYCLINE; |
| Eagene Biotechnology Co., Ltd. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Room 1301,Block A,China World Trade , Centre No. ; 41 Minzu Avenue , Nanning, Guangxi Zhuang Autonomous Regi CHINA | 05/12/2015 | 54 G - - 99 Animal By-Products and Extracts, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Rocket Fuel (Oyster Peptide Tablets) | Rocket Fuel (Oyster Peptide Tablets) | Rocket Fuel (Oyster Peptide Tablets) | Rocket Fuel (Oyster Peptide Tablets) | Rocket Fuel (Oyster Peptide Tablets) | Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil) | Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil) | Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil) | Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil) | Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil) |
| ELT Technology | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | 10f Tech-Building East Heping Road , Longhua Street, Baoan District Shenzhen , Guangdong, CHINA | 04/17/2015 | 31 - - - -- Coffee/Tea | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | Lose Weight Coffee Slim Delicious | Lose Weight Coffee Slim Delicious | FDA analysis found Sibutramine and Desmethyl Sibutramine in product. | FDA analysis found Sibutramine and Desmethyl Sibutramine in product. |
| Guangzhou Garden City (Biological) Health Food Factory | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | No. 128 Guangzhou Avenue , Dasan Industrial Park North , Guangzhou, CHINA | 04/23/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | La Jiao Shou Shen | La Jiao Shou Shen | Product contains undeclared sibutramine and phenolphthalein. | Product contains undeclared sibutramine and phenolphthalein. |
| Guangzhou Meilai Biotechnology Co., Ltd. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | No.128 North Guangzhou Ave , Chashan Industrial Park , Guangzhou, CHINA | 04/23/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | La Jiao Shou Shen | La Jiao Shou Shen | Product contains undeclared sibutramine and phenolphthalein | Product contains undeclared sibutramine and phenolphthalein |
| guangzhou p'product | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Chadong Industry Panyu , Shi Ji , Guangzhou, Guangdong CHINA | 04/03/2023 | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | Herba Plantaginis (Plantain Herb) | Firm/product previously listed on deactivated Import Alert 54-08 due to the presence of Digitalis. DWPE date: 04/06/2007. |
| Guangzhou Yan Xiang Co, LTD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | 105 Shahe Road , Baiyun , Guangzhou, Guangdong CHINA | 05/19/2015 | 54 Y - - 06 Bee Pollen (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Ultimate Formula Bee Pollen Capsules | Ultimate Formula Bee Pollen Capsules | Ultimate Formula Bee Pollen Capsules | FDA analysis found undeclared Sibutramine in product. | FDA analysis found undeclared Sibutramine in product | FDA analysis found undeclared Sibutramine in product |
| HENGS JEWELLRY LTD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Huan Shi Room 111 , East Rd , Guangzhou, Guangdong CHINA | 02/15/2018 | 31 A - - -- Coffee | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | H.I. Coffee (Herbal Instant Coffee) | H.I. Coffee (Herbal Instant Coffee) | H.I. Coffee (Herbal Instant Coffee) | H.I. Coffee (Herbal Instant Coffee) | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil. |
| Jiangsu Shenhua Pharmaceutical Co., Ltd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | No 188 Shenhuaroad,Jinhu County,Jiangsu , Huaian, Jiangsu CHINA | 09/22/2023 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 S - - 51 Tadalafil | CORDYCEPS EXTRACT POWDER | CORDYCEPS EXTRACT POWDER | Product contains Nortadalafil per FDA analysis | Product contains Nortadalafil per FDA analysis |
| Jiangsu Shenli Enterprise Co Ltd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | 1 88 Changshan Road , Shangguan Town , Jiangyin City, CHINA | 09/22/2023 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 S - - 51 Tadalafil | CORDYCEPS EXTRACT POWDER | CORDYCEPS EXTRACT POWDER | Product contains Nortadalafil per FDA analysis | Product contains Nortadalafil per FDA analysis |
| Kunming DaLi Industry & Trade Co., Ltd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | 372 Ren Min West Rd , Xishan , Kunming, Yunnan CHINA | 04/01/2015 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Dietary Supplements;Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | All Drug Products; Problem(s): APIs found in dietary supplement products | |
| La Sha City Limited Company | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | La Sha City Liberation Road no. 168 , La Sha City, Tibet CHINA | 05/15/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | France T253 Tablets | France T253 Tablets | France T253 Tablets | France T253 Tablets | Problem(s);Sildenafil found in product | Problem(s);Sildenafil found in product | Problem(s);Sildenafil found in product | Problem(s);Sildenafil found in product |
| Much New Limited | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Story Huangyan Mansion 8 , Huangyan, Zhejiang CHINA | 07/07/2015 | 54 F - - 50 Hawthorn (Herbal & Botanicals, not Teas) | 54 F - - 50 Hawthorn (Herbal & Botanicals, not Teas) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Joyful Slim (Puerarin- Chinese Yim Powder) | Slim 30 (Natural Herb Supplement for weight loss) | Joyful Slim (Puerarin- Chinese Yim Powder) | Slim 30 (Natural Herb Supplement for weight loss) | Slim 30 (Natural Herb Supplement for weight loss) | Joyful Slim (Puerarin- Chinese Yim Powder) | Slim 30 was found to contain undeclared Desmethyl Sibutramine | Slim 30 was found to contain undeclared Desmethyl Sibutramine | Slim 30 was found to contain undeclared Desmethyl Sibutramine | Slim 30 was found to contain undeclared Desmethyl Sibutramine | Slim 30 was found to contain undeclared Desmethyl Sibutramine | Slim 30 was found to contain undeclared Desmethyl Sibutramine |
| NET D ACTIVE NUTRA TRADING CO. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | 15 Yongjiang Road , Beilun Netd , Ningbo, Cn-Nota CHINA | 06/22/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Blue Steel Dietary Supplement | Blue Steel Dietary Supplement | Product contains undeclared Thianone; an analog of Sildenafil | Product contains undeclared Thianone; an analog of Sildenafil |
| No. 8 IIAlley | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | xia shi wei district , hu yong town baon district , guangdong, CHINA | 05/04/2015 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Dietary Supplements;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | All Drug Products;APIs found in dietary supplement products | |
| Qinghai Baojiantang Pharmaceutical Co., Ltd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Peoples Road 168 , Qinghai, CHINA | 09/25/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Male Sexual Stimulant- U.S.A. Wolf Brother Strong Man | Male Sexual Stimulant- U.S.A. Wolf Brother Strong Man | Male Sexual Stimulant- U.S.A. Wolf Brother Strong Man | Product was found to contain undeclared Sildenafil | Product was found to contain undeclared Sildenafil | Product was found to contain undeclared Sildenafil |
| Rizhao Rande Trading | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | No. 108 Heping Rd. , Shanghai, CHINA | 08/01/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Fuel Up High Octane Pills | Fuel Up Plus Pills | Fuel Up High Octane Pills | Fuel Up Plus Pills | Fuel Up High Octane Pills | Fuel Up Plus Pills | Fuel Up Plus Pills | Fuel Up High Octane Pills | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ; | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ; | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ; | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ; | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ; | Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills |
| Sha Double Nutra Biotech Coltd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | 11C No 1 Bldg 2005 Huangxing Rd , Shanghaishanghai, CHINA | 05/23/2016 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Anricetam Capsules | Adrafinil capsules | |
| Shenzhen Baoyitong | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Yi Wu 20E of the Habitat , Wenjin Road North , Shenzhen , Luohu District CHINA | 10/26/2016 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 F - - 99 Suppressant N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Aulijing Zi Su Body Fat Health II Dietary Supplement | Aulijing Zi Su Body Fat Health II Dietary Supplement | Aulijing Zi Su Body Fat Health II Dietary Supplement | FDA laboratory analysis confirmed product contains undeclared Sibutramine and Phenolphthalein. | FDA laboratory analysis confirmed product contains undeclared Sibutramine and Phenolphthalein. | FDA laboratory analysis confirmed product contains undeclared Sibutramine and Phenolphthalein. |
| Suzhou MyLand Pharm&Nutrition Inc. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | China (Jiangsu) Pilot Free Trade Zone Second Floor , China (Jiangsu) Pilot Free Trade Zone; Bachengzhen Kunshan , Suzhou, Jiangsu CHINA | 11/09/2015 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 61 N - - 99 Anti-Depressant N.E.C. | Propolis Extract Powder | Propolis Extract Powder | FDA analysis detected Tianeptine in product | FDA analysis detected Tianeptine in product |
| TopLife International | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Mingchengguoji Center No.98 # 1721 , Mid-Furong Rd.; Furong District , Changsha, Hunan CHINA | 10/04/2016 | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Meizi Evolution Slimming Softgel | Meizi Evolution Slimming Softgel | Meizi Evolution Slimming Softgel | Meizi Evolution Slimming Softgel | Meizi Evolution Slimming Softgel | FDA laboratory analysis confirmed product contains undeclared sibutramine | FDA laboratory analysis confirmed product contains undeclared sibutramine | FDA laboratory analysis confirmed product contains undeclared sibutramine | FDA laboratory analysis confirmed product contains undeclared sibutramine | FDA laboratory analysis confirmed product contains undeclared sibutramine |
| TopLife International Co., Ltd. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | No 388 Furong Mid Rd, Furong Dist , Changsha, Hunan CHINA | 09/12/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Mei Zi Super Power Fruits Capsules | Mei Zi Super Power Fruits Capsules | Mei Zi Super Power Fruits Capsules | Mei Zi Super Power Fruits Capsules | FDA laboratory analysis confirmed product contains undeclared subutramine. | FDA laboratory analysis confirmed product contains undeclared subutramine. | FDA laboratory analysis confirmed product contains undeclared subutramine | FDA laboratory analysis confirmed product contains undeclared subutramine |
| TopLife International (HK) | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | 1621, No 88, Dingwang Building , Furong Road , Changsha, Hunan CHINA | 03/02/2017 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Mei Zi Super Power Fruits Capsules | Mei Zi Super Power Fruits Capsules | Mei Zi Super Power Fruits Capsules | Mei Zi Super Power Fruits Capsules | FDA laboratory analysis confirmed product contains undeclared subutramine | FDA laboratory analysis confirmed product contains undeclared subutramine | FDA laboratory analysis confirmed product contains undeclared subutramine | FDA laboratory analysis confirmed product contains undeclared subutramine |
| xuancheng baicao plants industry and trade co.,ltd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | xuancheng economic developing zone , Anhui, Anweisheng CHINA | 11/28/2014 | 54 E - - -- Herbal and Botanical | 54 E - - -- Herbal and Botanical | Pro ArthMax | Super ArthGold | Undeclared APIs | Undeclared APIs |
| Zheng Xu Bin | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | CHINA | Huangshi Rd. , Baiyun District , Guangzhou, Guangdong CHINA | 11/10/2016 | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | Botanical Slimming Gold Version | Botanical Slimming Gold Version | Botanical Slimming Gold Version | FDA lab analysis found undeclared Sibutramine in product. Product is available for purchase by U.S. consumers on the website; http;//www.botanicalnow.com/online-store/!/~/cart. | FDA lab analysis found undeclared Sibutramine in product. Product is available for purchase by U.S. consumers on the website; http;//www.botanicalnow.com/online-store/!/~/cart. | FDA lab analysis found undeclared Sibutramine in product. Product is available for purchase by U.S. consumers on the website; http;//www.botanicalnow.com/online-store/!/~/cart. |
| Anhui Anke Biotechnology Co., Ltd. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CHINA | AnkeBio Building, , 669 Changjiang Road, West , Hefei, Anhui, CN-34 CHINA | 09/10/2009 | 64 R - - 18 Human Growth Hormone (Hormone) | 2/12/2003 | |
| Bao Shan Pharaceutical Factory | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CHINA | 1320 Beijin Road West , Shanghai, CHINA | 09/10/2009 | 60 R - - 08 Fenfluramine HCl (Anorexic) | Fenfluramine tablets 3/23/1998 | |
| Changchun GeneScience Pharmaceutical Co., Ltd. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CHINA | No. 72 Tianhe Street , Changchun High-Tech Dev. Zone , Changchun City, Jilin CHINA | 09/10/2009 | 64 R C P 18 Human Growth Hormone (Hormone), Human - Rx/Single Ingredient, Small Volume Parenteral | GenLei Jintropin Someatropin rDNA origin human growth hormone | 9/4/2003 |
| Jiangxi Chinabase Import & Export Co., Inc. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CHINA | Block C F/6 , Taoyuanlu; Xihu , Nanchang, Jiangxi CHINA | 09/10/2009 | 64 R - - 18 Human Growth Hormone (Hormone) | 2/12/2003 | |
| Shanghai United Cell Biotechnology Co., Ltd. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CHINA | 1150 Guiqiao Road , Pudongxin , Shanghai, Shanghai CHINA | 09/10/2009 | 64 R - - 18 Human Growth Hormone (Hormone) | 64 R - - 21 Somatropin (Hormone) | Genheal (somatropin rDNA) | Genheal (somatropin rDNA) | |
| Shanghi Shang-Amer Trading Co., Ltd | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CHINA | Room 1605, 666 Zhong Shan Xi Road , Shanghi, CHINA | 09/10/2009 | 64 R - - 18 Human Growth Hormone (Hormone) | 64 R - - 21 Somatropin (Hormone) | Genheal (somatropin rDNA) | Genheal (somatropin rDNA) | |
| Guangzhou Jiabei Henghui Pharmaceutical Technology Co., Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | 3rd Floor , No.4 Gaoxin Second Road, Huadong Town, Huadu District, Guangzhou , Guangzhou, Guangdong CHINA | 08/08/2024 | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | HERBAL DE-WORMER DROP SUPPLEMENT | COUGH DROP SUPPLEMENT | ANTIBIOTIC DROP SUPPLEMENT | UTI TREATMENT DROP SUPPLEMENT | |
| Hebei Meiwei Chinese Medicinal Herbs Co., LTD | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | No. 188 Henan Road , Anguo City, Hebei CHINA | 08/10/2016 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 - - - -- Human and Animal Drugs | All Products | All Products | |
| Mr. Su | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | Mega Long Road , Zhonshan, CHINA | 01/13/2020 | 54 Y - - 15 Hemp Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | Hemp oil for dogs | |
| Mutian | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | No. 68 Yucun Street , Wujiabao Zhen Huaiyin District , Jinan, Shandong CHINA | 01/21/2020 | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Mutian Cat Supplement for FIP | |
| Nantong MUTIAN Biotechnology Co., Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | 98 , Jianghai Industry Zone , Nantong, Jiangsu CHINA | 01/21/2020 | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Mutian Cat Supplement for FIP | |
| NEW XILAI (GUANGZHOU) BIOTECHNOLOGY CO., LTD. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | 3rd Floor , No. 4, Gaoxin 2nd Road, Huadong Town, Huadu District , Guangzhou, CHINA | 08/08/2024 | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | ANTIBIOTIC DROP SUPPLEMENT | HERBAL DE-WORMER DROP SUPPLEMENT | UTI TREATMENT DROP SUPPLEMENT | COUGH DROP SUPPLEMENT | |
| Qingdao chongbeitian Pet Products Co., Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | Li Jia Xicheng Cun, Huanxiu Office , Jimo District , Qingdao, Shandong CHINA | 07/27/2026 | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 72 A - - 99 Pet Cat Food N.E.C. | 72 A - - 99 Pet Cat Food N.E.C. | 72 A - - 99 Pet Cat Food N.E.C. | 72 E - - 99 Other Pet Food, N.E.C. | 72 E - - 99 Other Pet Food, N.E.C. | 72 E - - 99 Other Pet Food, N.E.C. | 72 G - - 99 Pet Treats, N.E.C. | 72 G - - 99 Pet Treats, N.E.C. | 72 G - - 99 Pet Treats, N.E.C. | Catnip Sticks (Star-shaped Lollipops) | Catnip Sticks | Silvervine Sticks | Silvervine Sticks | Catnip Sticks (Star-shaped Lollipops) | Catnip Sticks | Catnip Sticks (Star-shaped Lollipops) | Catnip Sticks | Silvervine Sticks | Catnip Sticks | Silvervine Sticks | Catnip Sticks (Star-shaped Lollipops) | |
| Shandong Bozhongyuan Biotech Co | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | 123 Quancheng Rd Jinan , Shandong, CHINA | 08/01/2017 | 62 G - - 99 Anti-Inflammatory N.E.C. | 64 D - - 99 Emollient, Lubricant, N.E.C. | 64 W - - 99 Irrigation Solution N.E.C. | 65 F - - 04 Water (Pharm Aid) For Inj, Sterile, U.S.P. | 65 F - - 99 Water N.E.C. (Pharmaceutic Aid) | 65 R - - 99 Replenisher N.E.C. | 66 G - - 99 Surgical/Prosthetic Aid N.E.C. | 68 L - - 23 Sterile Flush solution (Nonhuman) | 68 N - - 99 Small Hospital Practice Equipment, NEC (Nonhuman) | 68 P - - 10 Solutions (Nonhuman) | 68 P - - 99 Orthopedic, NEC (Nonhuman) | 68 Z - - 99 Animal Medical Devices, NEC | 87 M - - OZ Acid, hyaluronic, intraarticular | 88 P - - PM General purpose reagent | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE) | |
| SHANDONG NATURAL MICRON PHARM TE | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | 4th Floor , Yanxi No 3 C , Taian, CHINA | 05/19/2026 | 60 L - - 99 Analgesic, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | PALMITOYLETHANOLAMIDE | PALMITOYLETHANOLAMIDE | |
| Shandong Natural Micron Pharm Tech Co.,Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | Room 2006 , Detian Sohu , Taian, Shandong CHINA | 05/19/2026 | 60 L - - 99 Analgesic, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | PALMITOYLETHANOLAMIDE | PALMITOYLETHANOLAMIDE | |
| Shantou Olive Pharmaceutical Co.,Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | CHINA | NO. 4 Chaoshanlu Xixiang , Jinping , Shantou, Guangdong CHINA | 08/15/2016 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 - - - -- Human and Animal Drugs | All Products | All Products | |
| Qingdao Myjian Foodstuff Co., Ltd. | 72-07 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF POULTRY JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)" | CHINA | Zhangjialou Zhiju , Xiaonan , Qingdao, Shandong CHINA | 03/15/2016 | 72 B - - 02 Poultry Prod Pet Dog Food | 72 G - - 02 Poultry Products, Pet Treats | Duck Jerky Pet Treats | Duck Jerky Pet Treats | Problem; Amantadine | Problem; Amantadine |
| TIANJIN SHENGFA FOODSTUFFS CO., LTD. | 72-07 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF POULTRY JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)" | CHINA | Yangjiabai , Gaozhuangcun; Yangjiabozhen , Hangu District, Tianjin CHINA | 06/16/2014 | 72 B - - 02 Poultry Prod Pet Dog Food | 72 G - - 02 Poultry Products, Pet Treats | Chicken Jerky Pet Treats | Chicken Jerky Pet Treats | Problem;Amantadine | Problem; Amantadine |
| Weifang Sinogen Group Co.,Ltd. | 72-07 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF POULTRY JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)" | CHINA | D, Weifang, Shandong , No. 667 Weizhou Road , Weifang, Shandong CHINA | 10/26/2015 | 72 B - - 02 Poultry Prod Pet Dog Food | 72 G - - 02 Poultry Products, Pet Treats | Duck Jerky Pet Treats | Duck Jerky Pet Treats | ENROFLOXACIN; | ENROFLOXACIN; |
| Yantai Yummy Pet Food | 72-07 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF POULTRY JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)" | CHINA | North Of Huwang Village , Xinzhuang Town , Zhaoyuan, Shandong CHINA | 01/08/2016 | 72 B - - 02 Poultry Prod Pet Dog Food | 72 B - - 05 Comb Prod Pet Dog Food | 72 G - - 02 Poultry Products, Pet Treats | Duck Jerky Pet Treats | Duck Jerky Pet Treats | Duck Jerky Pet Treats | Problem; Amantadine | Problem; Amantadine | Problem; Amantadine |
| Zibo Dagongyuan Industrial & Trade Co., Ltd | 72-07 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF POULTRY JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)" | CHINA | Fushan Industry Park, Weigu , Zibo; Town, New , Zibo, Shandong CHINA | 06/27/2016 | 72 B - - 02 Poultry Prod Pet Dog Food | 72 B - - 05 Comb Prod Pet Dog Food | 72 G - - 02 Poultry Products, Pet Treats | Chicken Breast Jerky | Chicken Breast Jerky | Chicken Jerky Pet Treats | Problem: Amantadine | Problem: Amantadine | Problem; Amantadine ; |
| ALMENAT SAS | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | COLOMBIA | Av 39 Oeste No 10 Oeste , Cali, COLOMBIA | 07/09/2026 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | biQ-FEL | biQ-FEL | biQ-FEL | FDA�s Health Fraud Branch has determined that �biQ-FEL� appears to be an unapproved new drug for which introduction (or delivery for introduction) into interstate commerce would violate sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d), as discussed below. Furthermore, �biQ-FEL� appears to be a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352. Product contains undeclared sildenafil and tadalafil. | FDA�s Health Fraud Branch has determined that �biQ-FEL� appears to be an unapproved new drug for which introduction (or delivery for introduction) into interstate commerce would violate sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d), as discussed below. Furthermore, �biQ-FEL� appears to be a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352. Product contains undeclared sildenafil and tadalafil. | FDA�s Health Fraud Branch has determined that �biQ-FEL� appears to be an unapproved new drug for which introduction (or delivery for introduction) into interstate commerce would violate sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d), as discussed below. Furthermore, �biQ-FEL� appears to be a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352. Product contains undeclared sildenafil and tadalafil. |
| El Mana | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | COLOMBIA | Calle 74a 83-79 , Bogota, COLOMBIA | 12/10/2021 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | Nettle Powder (Ortiga) | |
| Herbal Nutraceutica Sas | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | COLOMBIA | Avenida 5 200 , ; ; ; ; ; OESTE , Cali, Valle Del Cauca COLOMBIA | 09/25/2015 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Ultra ZX Capsules | Ultra ZX Capsules | Ultra ZX Capsules | FDA analysis detected Sibutramine HCl in product. | FDA analysis detected Sibutramine HCl in product. | FDA analysis detected Sibutramine HCl in product. |
| THE CLICK LIFESTYLE SAS | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | COLOMBIA | Carrera 16 #37-48 Centr , Bucaramanga, COLOMBIA | 07/30/2025 | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. | 53 Q - - 99 Cosmetic Packaging and Labeling, N.E.C. | 53 Q - - 99 Cosmetic Packaging and Labeling, N.E.C. | 53 Q - - 99 Cosmetic Packaging and Labeling, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | MOUTHWASH | MOUTHWASH | TOPICAL TEAR GROOVE CLEANSER SOLUTION | COLLAGEN MULTI ADVANCE FOR PETS | MOUTHWASH | COLLAGEN MULTI ADVANCE FOR PETS | TOPICAL TEAR GROOVE CLEANSER SOLUTION | |
| ATM, Inc. (Curacao) | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | CURACAO | Curazao Free Zone , Maduro Plaza , Willemstad, CURACAO | 09/18/2009 | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | Pantene hydrating curls (counterfeit); 11/5/04 | 601(a) | PSEUDOMONAS : AERUGINOSA; |
| Biomedical Holding AVV | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CURACAO | Unknown , Curacao, CURACAO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 |
| Curacao Services N V | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CURACAO | Unknown , Curacao, CURACAO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | 3/19/1993 | 3/19/1993 | 3/19/1993 | 3/19/1993 | 3/19/1993 | 3/19/1993 | 3/19/1993 | 3/19/1993 |
| Elina Pharmaceuticals (aka viagraep.com) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CYPRUS | PO Box 633 , Paphos, CYPRUS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 ; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Viagraep (aka Elina Pharmaceuticals) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CYPRUS | PO Box 633 , Paphos, CYPRUS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| A. Werner & Co. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | CZECH REPUBLIC | 111 , 21 , Prague, CZECH REPUBLIC | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 9/23/1993 | All prescription drugs 9/23/1993 | All prescription drugs 9/23/1993 | All prescription drugs 9/23/1993 | All prescription drugs 9/23/1993 | All prescription drugs 9/23/1993 | All prescription drugs 9/23/1993 | All prescription drugs 9/23/1993 | |
| Vetcur Biotec Aps | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | DENMARK | Feldumvej 35 , Haderslev, DENMARK | 04/19/2016 | 54 A - - 99 Vitamin, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | DiVet for horses; nutrition for the digestion | DiVet for cats; organic syrup based supplement | NeVet for cats; organic syrup based supplement | NeVet for cats; organic syrup based supplement | DiVet for cats; organic syrup based supplement | DiVet for horses; nutrition for the digestion | ReVet Feed supplement for cats and kittens | The Red Oilbased feed supplement for horses | ViVet Feed supplement for cats and kittens | ImVet Feed supplement for cats and kittens | The Green Oilbased feed supplement for horses | Product labels and website made medical claims | Product labels and website made medical claims | Product labels and website made medical claims | Product labels and website made medical claims | Product labels and website made medical claims | Product labels and website made medical claims |
| Lifestyle Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | DOMINICA | 10 King George V Street , Roseau, DOMINICA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | - 3/14/2000; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Rey Fruit S R L | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | DOMINICAN REPUBLIC (THE) | Zona Franca Puerto Plata Nave A-7 , Puerto Plata, Zona Franpuerto Plata, Zon, DOMINICAN REPUBLIC (THE) | 01/26/2016 | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | Exfoliating Cream | Problem(s); STAPHYLOCOCCUS INTERMEDIUS; STAPHYLOCOCCUS LENTUS; STAPHYLOCOCCUS AUREUS; BACILLUS LENTUS; BACILLUS PUMILUS; BACILLUS LICHENIFORMIS; BACILLUS VALLISMORTIS; BREVBACILLUS CHOSHINENSIS; LYSINBACILLUS |
| ZAPHIREDELCOR | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | ECUADOR | Jose Figueroa 08-74 y Vallejo Larrea , Quito, Pichincha ECUADOR | 09/04/2019 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Mero Macho Liquid Supplement | Mero Macho Liquid Supplement | Mero Macho Liquid Supplement | Mero Macho Liquid Supplement | Mero Macho Liquid Supplement | FDA laboratory analysis confirmed product contains undeclared Tadalafil | FDA laboratory analysis confirmed product contains undeclared Tadalafil | FDA laboratory analysis confirmed product contains undeclared Tadalafil | FDA laboratory analysis confirmed product contains undeclared Tadalafil | FDA laboratory analysis confirmed product contains undeclared Tadalafil |
| CHEMIPOWER OU | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | ESTONIA | Parnu Mnt 141 , Tallinn, ESTONIA | 06/22/2026 | 62 G - - 99 Anti-Inflammatory N.E.C. | CARNO GEL | |
| Vitry Sa | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | FRANCE | Pa De La Foret , Bignon, FRANCE | 01/06/2011 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Longcils Boncza Cake Mascara Black | 601(a) Gram Positive rods non-sporeforming |
| Pharmacie Chatel | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | FRANCE | 38 Avenue de Clichy , Paris, Paris FRANCE | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All preseciption drugs 5/24/1996 | All preseciption drugs 5/24/1996 | All preseciption drugs 5/24/1996 | All preseciption drugs 5/24/1996 | All preseciption drugs 5/24/1996 | All preseciption drugs 5/24/1996 | All preseciption drugs 5/24/1996 | All preseciption drugs 5/24/1996 | |
| AB SCIENCE | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | FRANCE | Avenue Du Midi , Cournon D-Auver, FRANCE | 07/02/2026 | 58 D - - 99 Antineoplastic, NEC | 58 S - - 99 Tumor Necrosis Factor (TNF) Inhibitor, NEC | 60 Y - - 99 Inhibitor (Growth Factor) N.E.C. | 64 T - - 09 Imatinib mesylate (Immunosuppressive) | 64 U - - 99 Inhibitor N.E.C. | MASIVET (Masitinib) | MASIVET (Masitinib) | MASIVET (Masitinib) | MASIVET (Masitinib) | MASIVET (Masitinib) | |
| Centre Specialites Pharmaceutiques | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | FRANCE | Avenue Du Midi , Cournon D?Auvergnecournon D, Auvergne FRANCE | 07/02/2026 | 58 D - - 99 Antineoplastic, NEC | 58 S - - 99 Tumor Necrosis Factor (TNF) Inhibitor, NEC | 60 Y - - 99 Inhibitor (Growth Factor) N.E.C. | 64 T - - 09 Imatinib mesylate (Immunosuppressive) | 64 U - - 99 Inhibitor N.E.C. | MASIVET (Masitinib) | MASIVET (Masitinib) | MASIVET (Masitinib) | MASIVET (Masitinib) | MASIVET (Masitinib) | |
| GHO AHK SPRL | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | FRANCE | 14 Rue Des Vosges , Berrwiller, Haut-Rhin FRANCE | 09/30/2025 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 66 X - - 99 Homeopathic N.E.C. | 70 E - - 99 Additives, N.E.C. | 70 M - - 02 Horse Mixed Feed Ration | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | |
| Virbac Sa | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | FRANCE | 1 Main St , Carros, FRANCE | 06/22/2015 | 54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | PRONEFRA 60ML | PRONEFRA 60ML | |
| Inspira Cosmetics Gmbh | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | GERMANY | Hirzenrott 13 , Aachen, North Rhine-Westphalia GERMANY | 12/21/2016 | 53 L - - 99 Other Skin Care Preparations, N.E.C. | Peel Off Alginate Bio Marine Extract | BACILLUS FIRMUS; BREVIBACILLUS CHOSHINESSIS; GEOBACILLUS TOEBII; BACILLUS CIRCULANS; BACILLUS AMYLOLIQUIFACIENS; BACILLUS ATROPHAEUS; | BACILLUS : CEREUS; BACILLUS : MYCOIDES; STAPHYLOCOCCUS : LENTUS; BACILLUS : THURINGIENSIS; STAPHYLOCOCCUS : AUREUS; BACILLUS : SUBTILIS; |
| Krauter Mix GmbH | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | GERMANY | Wiesentheider Str. 4 , Abtswind, Bavaria GERMANY | 04/03/2023 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Dried Bulk Plantain | Firm/product previously listed on deactivated Import Alert 54-08 due to the presence of Digitalis. DWPE date: 07/01/1997. |
| Paul Muggenburg Gmbh & Co | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | GERMANY | Bahnhofstr. 2 , Alveslohe, Schleswig-Holstein GERMANY | 04/03/2023 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Dried Bulk Plantain | Firm/product previously listed on deactivated Import Alert 54-08 due to the presence of Digitalis. DWPE date: 07/01/1997. |
| International Products | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GERMANY | D-3000 , Beckstr. 27 , Hanover, Lower Saxony GERMANY | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | All prescription drugs; 3/1/1993 | |
| Quotaz S A | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GERMANY | P7 20-21 (Planken) , Mannheim 1, GERMANY | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | |
| Schneider, Juergen | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GERMANY | Georgenschwaigstr. 6 , Munich, Bavaria GERMANY | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 |
| GEROCELL PHARMA GMBH | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | GERMANY | Ludwig-Feuerbach-Str. 36 , Nuremberg, Bavaria GERMANY | 12/07/2021 | 60 B - - 20 Methionine (Acidifier) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 Z - - 99 Animal Medical Devices, NEC | Retina and Pigment Epithelium Molecular Nutrition (eye drops) | Retina and Pigment Epithelium Molecular Nutrition (eye drops) | Retina and Pigment Epithelium Molecular Nutrition (eye drops) | |
| Banbara Enterprises Limited | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | GHANA | P O Box 7789 , Accra, GHANA | 04/23/2015 | 53 P - - 99 Other Cosmetic Raw Materials, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | Cryptolepsis Sanguiolenta roots; dried & powdered- bulk ingredient for cosmetic products | Cryptolepsis Sanguiolenta roots; dried & powdered- bulk ingredient for cosmetic products | Problem(s); Pseudomonas aeruginosa | Problem(s); Pseudomonas aeruginosa |
| Geo Medicore Limited | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | GHANA | Factory: Plot No. 312 To 315 , Kuntunse; Ghana , Accra, GHANA | 08/07/2025 | 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 03 Vitamin B2 (Riboflavin) | 54 A - - 04 Vitamin B6 (Pyridoxine) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - -- A-Histaminic | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | GML-APETI Multivitamin tablets | GML-APETI Multivitamin tablets | GML-APETI Multivitamin tablets | Gml apeti | GML-APETI Multivitamin tablets | Gml apeti | GML-APETI Multivitamin tablets | Gml apeti | Product contains Cyproheptadine Hydrochloride. | Product contains Cyproheptadine Hydrochloride. | Product contains Cyproheptadine Hydrochloride. | Product contains Cyproheptadine per FDA analysis | Product contains Cyproheptadine Hydrochloride. | Product contains Cyproheptadine per FDA analysis | Product contains Cyproheptadine Hydrochloride. | Product contains Cyproheptadine per FDA analysis |
| Global Medica (aka VIAGRA.nu; Mr. Mailman, Ltd) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GIBRALTAR | unknown , unknown, GIBRALTAR | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Longevity Products, Ltd. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GIBRALTAR | P.O. Box 561, Suite 6/588 , 28 City Mill Lane , Unknown, GIBRALTAR | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 2/20/1998 | All prescription drugs 2/20/1998 | All prescription drugs 2/20/1998 | All prescription drugs 2/20/1998 | All prescription drugs 2/20/1998 | All prescription drugs 2/20/1998 | All prescription drugs 2/20/1998 | All prescription drugs 2/20/1998 |
| B Mougios and Co | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GREECE | Pittakoy , 23 T K , Thessaloniki, Thessaloniki GREECE | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | All prescription drugs FDA is aware of other names being used. Any variation to this name, including but not limited to Georgios, Georgiadou, B&G Moyres, etc. and also using other cities in Greece, should be viewed as the same operation and should be subject to this Import Alert. | |
| Cybermedrx (aka John W.) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GREECE | T.Th. 17205 , Athens, Attica GREECE | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 3/29/2000 | All Prescription Drugs; 3/29/2000 | All Prescription Drugs; 3/29/2000 | All Prescription Drugs; 3/29/2000 | All Prescription Drugs; 3/29/2000 | All Prescription Drugs; 3/29/2000 | All Prescription Drugs; 3/29/2000 | All Prescription Drugs; 3/29/2000 |
| Medicall (Max Schmidt) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GREECE | P.O. Box 373 , Rhodes, Rhodes GREECE | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/5/2002 | All prescription drugs;3/5/2002 | All prescription drugs;3/5/2002 | All prescription drugs;3/5/2002 | All prescription drugs;3/5/2002 | All prescription drugs;3/5/2002 | All prescription drugs;3/5/2002 | All prescription drugs;3/5/2002 |
| Olympia Skouvara | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GREECE | Agorakritou 36 , ST , Athens, Athina GREECE | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | |
| Vipharm Pharmaceutical Products (OL Skouvara & Co.) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | GREECE | Epaminoda Street 82 , Thiva, Voiotias GREECE | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | All prescription drugs 7/22/1997 | |
| Hong Kong Tianlong Technology International Group Company | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | HONG KONG SAR | 20/F , Hua Chiao Commercial Centre , Mong Kok, Kowloon HONG KONG SAR | 05/15/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | France T253 Tablets | France T253 Tablets | France T253 Tablets | France T253 Tablets | Problem(s);Sildenafil found in product. | Problem(s); Sildenafil found in product | Problem(s); Sildenafil found in product | Problem(s);Sildenafil found in product |
| Hongkong Jiuyuejiu Biology Technology CO., LTD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | HONG KONG SAR | 1226, Tsim Sha Tsui , Unknown, HONG KONG SAR | 06/01/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Bull Tablets | Bull Tablets | Bull Tablets | Bull Tablets | Problem(s); Sildenafil and Tadalafil found in product. | Problem(s); Sildenafil and Tadalafil found in product. | Problem(s); Sildenafil and Tadalafil found in product. | Problem(s); Sildenafil and Tadalafil found in product. |
| Jin Lian | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | HONG KONG SAR | Kowloon , No. 122 Hong Kong Street , Bya Kowloon Bay Horngjaan, HONG KONG SAR | 01/25/2017 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Black 4K Capsules (Bl4ck 4K)Dietary Supplement | Black 4K Capsules (Bl4ck 4K)Dietary Supplement | Black 4K Capsules (Bl4ck 4K)Dietary Supplement | FDA laboratory analysis confirmed product contains undeclared Sildenafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil |
| Wuhan 3B Scientific Corporation | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | HONG KONG SAR | No. 122 Hongkong Steer , Kowloon Bay , Kowloon Bay, Horngjaan, HONG KONG SAR | 07/17/2017 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | Vegetal Vigra Capsules | Vegetal Vigra Capsules | Product was found to contain undeclared Sildenafil | Product was found to contain undeclared Sildenafil |
| Joui Limited | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | HONG KONG SAR | Room 1402 , Lap Fai Bldg; 6-8 Pottinger Street , Central, Hong Kong Island HONG KONG SAR | 09/10/2009 | 66 S - - 51 Tadalafil | Eriyos Pocket strips | 8/2/2005 |
| Libertarian Solutions | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | HONG KONG SAR | GPO Box 12496 , Unknown City, HONG KONG SAR | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 12/22/1997 | All prescription drugs 12/22/1997 | All prescription drugs 12/22/1997 | All prescription drugs 12/22/1997 | All prescription drugs 12/22/1997 | All prescription drugs 12/22/1997 | All prescription drugs 12/22/1997 | All prescription drugs 12/22/1997 |
| Aspiration Intl | 86-11 | "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination" | HONG KONG SAR | Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR | 06/09/2015 | 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | |
| CUCKU ENTERPRISES PVT. LTD. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | INDIA | G - 12 , Delhi, Delhi INDIA | 05/15/2013 | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | Herbal Neem Powder | 601(c)Patoea spp.; B. licheniformis; B. curculans; and B. vallismortis |
| SHREE SADGURU MASALA & SPICES INDUSTRIES PVT.LTD. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | INDIA | A -231.T.T.C.Industrial Area,M.I.D.C , Mahape,Navi Mumbai-400708 , Mumbai (Navi Mumbai), Maharashtra INDIA | 04/04/2017 | 53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati | 53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes) | 53 G - - 11 Children Novelty Body Paints | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Color Marathon Holi Colors | Color Marathon Holi Colors | Color Marathon Holi Colors | Color Marathon Holi Colors | Color Marathon Holi Colors | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie; | BACILLUS : CEREUS; BACILLUS : MYCOIDES; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : LENTUS; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie; | BACILLUS : PUMILUS; STAPHYLOCOCCUS : LENTUS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : MYCOIDES; BACILLUS : CEREUS; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie; | BACILLUS : CEREUS; BACILLUS : MYCOIDES; STAPHYLOCOCCUS : LENTUS; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie; | BACILLUS : MYCOIDES; BACILLUS : CEREUS; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : LENTUS; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie; | STAPHYLOCOCCUS : LENTUS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : PUMILUS; BACILLUS : MYCOIDES; BACILLUS : CEREUS; |
| Shree Sadguru Tea Agency | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | INDIA | 72/A Gunj Bazzaar , Nadiad, Gujarat INDIA | 04/04/2017 | 53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati | 53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes) | 53 G - - 11 Children Novelty Body Paints | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Color Marathon Holi Colors | Color Marathon Holi Colors | Color Marathon Holi Colors | Color Marathon Holi Colors | Color Marathon Holi Colors | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie | BACILLUS : CEREUS; BACILLUS : MYCOIDES; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : LENTUS; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie | BACILLUS : PUMILUS; STAPHYLOCOCCUS : KLOOSII; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : MYCOIDES; BACILLUS : CEREUS; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie | BACILLUS : CEREUS; BACILLUS : MYCOIDES; STAPHYLOCOCCUS : KLOOSII; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie | BACILLUS : MYCOIDES; BACILLUS : CEREUS; BACILLUS : PUMILUS; BACILLUS : THURINGIENSIS; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; STAPHYLOCOCCUS : KLOOSII; | The microbiological findings showed that the product contains microbial contents exceeding current regulatory limits; and includes eye-infection causing microorganisms. Kocuria kristinae; Globicatella sulfidifaciens; Streptococcus thoraltensis; Brevibacillus choshinensis; Erysipelothrix rhusiopathie | STAPHYLOCOCCUS : KLOOSII; LEUCONOSTOC : MESENTEROIDES SUBSP. CREMORIS; BACILLUS : THURINGIENSIS; BACILLUS : PUMILUS; BACILLUS : MYCOIDES; BACILLUS : CEREUS; |
| Ronak Exim Pvt. Ltd. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | INDIA | Sant Kabir road, Behind Gendigate police station , Vadodara, Gujarat INDIA | 09/18/2025 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - -- A-Histaminic | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | DR. Ico Cyproheptadine with multi vitamin tablets | DR. ICO Cyproheptadine with Multivitamin Tablets | DR. Ico Cyproheptadine with multi vitamin tablets | DR. Ico Cyproheptadine with multi vitamin tablets | DR. ICO Cyproheptadine with Multivitamin Tablets | Product contains Cyproheptadine per FDA analysis | Product contains Cyproheptadine Hydrochloride. | Product contains Cyproheptadine per FDA analysis | Product contains Cyproheptadine per FDA analysis | Product contains Cyproheptadine Hydrochloride. |
| ZAHIDI PHARMACEUTICAL PVT LTD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | INDIA | Ldt J-1601/10 3rd Phase , Gujarat, INDIA | 10/03/2025 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 61 X - - -- A-Histaminic | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Zahidi vita Plus | Zahidi vita Plus | Zahidi vita Plus | Product contains Cyproheptadine per FDA analysis | Product contains Cyproheptadine per FDA analysis | Product contains Cyproheptadine per FDA analysis |
| Ajanta Pharma Limited | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | 318 Linking Road , Mumbai, INDIA | 09/10/2009 | 65 P D - 02 Sildenafil Citrate (Regulator), Human - Rx/Combination Ingredient | Kamagra (Sildenafil 100 mg. oral tablet) | 4/4/2003 |
| Cipla Limited | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | Lal Bahadur Shastri Marg , Mumbai, Maharashtra INDIA | 09/10/2009 | 56 - - - -- Antibiotics (Human/Animal) | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/2/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | |
| Dr. B.A. Prasanna | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | 225 10th Main, , 4th Cross , Bangalore, INDIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 |
| IASO Pharmaceuticals Private Limited | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | G-10, 11, 12 & 37 CSC Vardhman Market , Vigyan Vihar , Delhi, INDIA | 06/08/2017 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Mags International Pvt. Ltd. c/o Samit Chhabra | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | 89 719a Hemkunt Chanbers , New Delhi, Delhi INDIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 8/3/2001 | All Prescription Drugs;8/3/2001 | All Prescription Drugs;8/3/2001 | All Prescription Drugs;8/3/2001 | All Prescription Drugs;8/3/2001 | 8/3/2001 | All Prescription Drugs;8/3/2001 | All Prescription Drugs;8/3/2001 |
| Makhmalchi, Hamid Reza | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | Pearl Villa , 6'th Cross Road , Bangalore, Karnataka INDIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/3/2001 | All prescription drugs;8/3/2001 | All prescription drugs;8/3/2001 | All prescription drugs;8/3/2001 | All prescription drugs;8/3/2001 | All prescription drugs;8/3/2001 | All prescription drugs;8/3/2001 | All prescription drugs;8/3/2001 |
| Meridan Marketing Services | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | 1676 Brinkivasa Colony , 1st Main 2nd Cross Road; Mission Road , Bengaluru, Karnataka INDIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 |
| One World Pharma Pvt. Ltd. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | 2nd Fl , 201/202/203 Makwana Road , Mumbai, Maharashtra INDIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | |
| Shah & Shah Intraocular Lens (Pvt) Ltd | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | 23 Russell Street , Next To 1 J M D H Road Joka 743 512 , Calcutta, INDIA | 09/10/2009 | 55 R - - 14 Hydroxypropyl Methylcellulose (Pharmaceutic Necessity - Suspending Agent) | Sterile opthalmic hydroxypropyl methylcellulose 2% solution USP for intraocular use | 4/7/1995 |
| Unicure Remedies Pvt. Ltd. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | F25 Gorwa , Vadodara, Gujarat INDIA | 09/10/2009 | 66 S - - 51 Tadalafil | Tadalafil tablets | |
| Vinay Medical Stores | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | Raja Delux Complex , Nyderabad, INDIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | |
| Wicks Pharmaceuticals Pvt Ltd | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDIA | Mission Road , Bangalore, INDIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 |
| PT Surya Garutindah (Perseroan Terbatas) | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | INDONESIA | JL Pataruman , No. 47 Garut 44151 , Jawa Barat, INDONESIA | 02/02/2010 | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 |
| Hamada Dayateknindo P.T. (aka viagragogo.com) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDONESIA | Jln. Sangrila Sakti I No. 15 , Jakarta Selatan, Dki Jakarta INDONESIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 3/14/2000; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; |
| Viagragogo (aka Hamada Dayateknindo, P.T.) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | INDONESIA | Jln. Sangrila Sakti I No. 15 , Jakarta Selatan, Dki Jakarta INDONESIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 3/14/2000; This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| USA Medicine.com Ltd. (Mr. Mark Caron) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | IRELAND | 123 Sanford Wood , Swords, Dublin IRELAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 |
| COPPERFIELD EQUINE THERAPY | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | IRELAND | Copperfield Stuf , Kilfrush, IRELAND | 02/26/2018 | 54 F - - 03 Angelica (Herbal & Botanicals, not Teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 70 M - - 02 Horse Mixed Feed Ration | 70 Y - - 99 Animal Feeds, N.E.C. | Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement | |
| Israel Pharmacy Ltd | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ISRAEL | Unknown , Petah Tikva, ISRAEL | 04/18/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic) | 60 T - - 15 Naltrexone (Antagonist) | Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules | |
| Magic of Nature c/o Olga Buchman | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ISRAEL | P.O. Box 448 , Nes-Tziona, ISRAEL | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 |
| Nezah Israel Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ISRAEL | 11 Nezah Israel St , Tel Aviv, ISRAEL | 04/18/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic) | 60 T - - 15 Naltrexone (Antagonist) | Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules | |
| Arava Pet Spa Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | ISRAEL | 3 Bazlete St. - Mitzpe Sapir Industrial , Tzur Yigal, ISRAEL | 09/29/2023 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 Y - - 01 Sulfsalazine (Anti-Inflammatory, Part II) | 77 O - - GQ Ear irrigation kit | Pet Ear Infections Treatment | Pet Ear Infections Treatment | Pet Ear Infections Treatment | Pet Ear Infections Treatment | |
| Gamma Croma S.P.A. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | ITALY | Km 29 , Strada Statale Paullese 415 , Vaiano Cremasco, Cremona ITALY | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye shadow | STAPHYLOCOCCUS : HOMINIS; BACILLUS : CEREUS; | |
| Anagen (aka DMC di Vezzi Roberto) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ITALY | Via Emilia 30 , Curno, BG ITALY | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | |
| DMC di Vezzi Roberto (aka anagen.net) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ITALY | Via Emilia 30 , Curno, BG ITALY | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 ; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Farmacia Cerati di Zambonardi Aldo | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ITALY | Via Roma 17 , S Damiano D'Asti, Asti ITALY | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 |
| Quotaz S. A. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ITALY | Via Cervi # 6 , Palidano, MN ITALY | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | |
| Fatro Spa | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | ITALY | Via Emilia 285 , Ozzano Dell'Emilia, Bologna ITALY | 07/16/2026 | 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 C - - 99 Nutrient/Tonic N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | METABOLASE | METABOLASE | METABOLASE | METABOLASE | METABOLASE | METABOLASE | |
| Daromale International Trading | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | JAMAICA | 125 Maxfield Ave , Kingston, JAMAICA | 10/26/2020 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Black Stallion Bedroom Tonic | Black Stallion Bedroom Tonic | Black Stallion Bedroom Tonic | FDA laboratory analysis confirmed product contains Sildenafil. | FDA laboratory analysis confirmed product contains Sildenafil. | FDA laboratory analysis confirmed product contains Sildenafil. |
| Ens | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 501 Hanam Venture Center 239 , Gyenonggi-do, KOREA (THE REPUBLIC OF) | 02/03/2016 | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | Green Essence Lifting Facial Mask Pack | BACILLUS : CEREUS; |
| Gc Logistics Corporation | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 501 Lohas Ave , Hwaseong, KOREA (THE REPUBLIC OF) | 06/16/2014 | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | Eye Toner Panda's Dream Eye Patch | Problem; Gram-positive cocci |
| Greenb Cosmetic Co. Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 147 Block 8 Namdong Industrial Complex , 713-16 Gojan-Dong , Incheon, KOREA (THE REPUBLIC OF) | 06/04/2014 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Mascara | Candida pelliculosa Aerobic plate count Yeast and Mold | STAPHYLOCOCCUS : AUREUS; CANDIDA; |
| H & K Korea Corp. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | No. 307 3f Woori Bldg. 47-17 Sin , Seoul, KOREA (THE REPUBLIC OF) | 01/18/2013 | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. |
| Pacific Corporation | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | CPO Box 195 , Seoul, KOREA (THE REPUBLIC OF) | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | eye shadow; 5/16/95 | 601(a) | PSEUDOMONAS : STUTZERI; |
| Seowoo Int Corp | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 3 Ga Chungjeong-Ro, Seodaemun-gu , 229 Chungdong , Seoul, Seoul KOREA (THE REPUBLIC OF) | 02/02/2010 | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 |
| TONYMOLY Co., Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 180 Bangbae-ro , Seoco-gu, Seoulteugbyeol-si KOREA (THE REPUBLIC OF) | 06/16/2014 | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | Eye Toner Panda's Dream Eye Patch | Gram-positive cocci |
| VOTRE COSMETIC CO,. LTD | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 71 Mayu-Ro 186 Beon-Gil , Gyeonggi-Do, KOREA (THE REPUBLIC OF) | 02/07/2020 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Mascara Falscara | Violative for APC and Yeast & Mold |
| Dae Han Corporation | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | KOREA (THE REPUBLIC OF) | Bundang-Gu , 703 Sungwoo Starus, 16 Gumi-Ro , Seongnam-si, KYONGGi KOREA (THE REPUBLIC OF) | 06/30/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Power Khan Pills | Undeclared Sulfoaildenafil and Acetildenafil |
| SamjinPharm | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | KOREA (THE REPUBLIC OF) | 338-8 Seokyo-dong , Mapo-ku , Seoul, KOREA (THE REPUBLIC OF) | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | |
| NATURAL PRO CO.,LTD. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | KOREA (THE REPUBLIC OF) | 17-2 Yeouidonggil17beon-Gil , Jeongnam-Myeon , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) | 09/08/2023 | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 72 B - - 99 Pet Dog Food N.E.C. | 72 B - - 99 Pet Dog Food N.E.C. | 72 B - - 99 Pet Dog Food N.E.C. | NOCK Probiotics Dental Support | NOCK Probiotics Kidney Support | NOCK Probiotics Respiratory Support | NOCK Probiotics Kidney Support | NOCK Probiotics Dental Support | NOCK Probiotics Respiratory Support | |
| Con Tech Korea Co. Ltd. | 86-11 | "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination" | KOREA (THE REPUBLIC OF) | Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA (THE REPUBLIC OF) | 06/16/2014 | 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | |
| Contech Korea | 86-11 | "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 970-14 Wolchul-Dong , Gwangju, KOREA (THE REPUBLIC OF) | 06/16/2014 | 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | |
| MAX LOOK CONTACT LENS / KIM | 86-11 | "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination" | KOREA (THE REPUBLIC OF) | 105 Hyeopseok-Ri , Namcheon-Myeon , Gyeongsan, Gyeongsangbugdo KOREA (THE REPUBLIC OF) | 10/17/2013 | 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II |
| Achlim Trading Sdn Bhd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 1-113a Plaza Idaman , Jalan Gombak; MEDAN IDAMAN , Kuala Lumpur, Wilayah Persekutuan MALAYSIA | 09/07/2016 | 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | KINGDOM HONEY FOR HER | KINGDOM ROYAL HONEY | Royal Honey VIP | KINGDOM HONEY FOR HIM | Royal Honey VIP | Etumax Royal Honey For Him | KINGDOM HONEY FOR HER | KINGDOM HONEY FOR HIM | KINGDOM ROYAL HONEY | Royal Honey VIP | KINGDOM HONEY FOR HER | KINGDOM HONEY FOR HIM | KINGDOM ROYAL HONEY | Royal Honey VIP | Etumax Royal Honey For Him | Etumax Royal Honey For Him | Etumax Royal Honey For Him | KINGDOM HONEY FOR HIM | KINGDOM ROYAL HONEY | KINGDOM HONEY FOR HER | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis |
| Biotivity SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | Lot 6384 , Jalan Gelung Pepuyu , Bota, Perak MALAYSIA | 06/29/2017 | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Royal Honey VIP | Royal Honey VIP | Royal Honey VIP | Royal Honey VIP | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis |
| CAVERFLO TEXAS TRADING | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 117 Lorong Bunga Raya 5 , Sungai Petani, Kedah MALAYSIA | 09/26/2017 | 31 A - - -- Coffee | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | CaverFlo Natural Herbal Coffee | CaverFlo Natural Herbal Coffee | CaverFlo Natural Herbal Coffee | CaverFlo Natural Herbal Coffee | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil |
| Dose Vital Manufacturing SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | No. 8a Jalan Kelang Lama , Kuala Lumpur, Wilayah Persekutuan MALAYSIA | 06/08/2018 | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Product was found to contain undeclared Tadalafil. | Product was found to contain undeclared Tadalafil. | Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil |
| Dr Foerster (M) Sdn Bhd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | No. 95 Jalan Nilam 1/2 , Taman Technologi Tinggi Subang , Shah Alam, Selangor MALAYSIA | 11/27/2018 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Dr Foerster Detox Plus Food Supplement | Dr Foerster Detox Plus Food Supplement | Ultra Detox Capsules | Ultra Detox Capsules | Ultra Detox Capsules | FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine. | FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine. | FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil |
| DRS SECRET WORLDWIDE MANUFACTURING SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | No 42 Jalan Todak , 2 , Seberang Perai Tengah, Pulau Pinang MALAYSIA | 05/19/2016 | 31 A - - -- Coffee | 36 C - - 04 Honey | 36 C - - 04 Honey | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | DR's SECRET BIO HERBS COFFEE | Royal King Honey (Food Supplement) | Mens Bio Honey Malaysia Recipe | Mens Bio Honey Malaysia Recipe | Royal King Honey (Food Supplement) | Mens Bio Honey Malaysia Recipe | Royal King Honey (Food Supplement) | DR's SECRET BIO HERBS COFFEE | Royal King Honey (Food Supplement) | Mens Bio Honey Malaysia Recipe | Problem(s); Product contains Tadalafil per FDA analysis. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Problem(s); Product contains Tadalafil per FDA analysis. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil |
| EXPO CONNECT SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | Street Mall One South , Seri Kembangan, Selangor MALAYSIA | 06/26/2019 | 36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | Helmi's Honey VIP Jantanak Dream (Royal Honey); FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. |
| Fikrysz | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 14 Lorong Saga , Sungai Petani, MALAYSIA | 04/14/2023 | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Natural Herbs Coffee | Product contains Sildenafil and Tadalafil per FDA analysis |
| GOLD FOOD RESOURCES SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | Lot 331 Perusahaan Buloh 3 , Ipoh, MALAYSIA | 03/17/2023 | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 S - - 51 Tadalafil | BLACK HORSE VITAL HONEY | BLACK HORSE VITAL HONEY | BLACK HORSE VITAL HONEY | BLACK HORSE VITAL HONEY | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis |
| HERAMIOS SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 5-17 Jalan Pju 1a/7 , Petaling Jaya, Selangor MALAYSIA | 06/08/2018 | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil. | Product was found to contain undeclared Tadalafil. |
| KHAN aLASSAL | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | Unknown , Selangor, UNKNOWN MALAYSIA | 05/10/2019 | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | Gold Herbs Royal King Honey with Herbal Extracts; Note: FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. |
| KINGDOM ETUMAX BIO SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | Seksy , 102 Jalan Gasing , Petaling, Selangor MALAYSIA | 05/02/2023 | 36 C - - -- Honey | 36 C - - -- Honey | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Kingdom Honey Royal Honey | Etumax Royal Honey | Kingdom Honey Royal Honey | Etumax Royal Honey | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. |
| Kingdom Honey SDN. BHD. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 569-364 Sentul Boulevard , Jalan Matang 3 , Kuala Lumpur, Wilayah Persekutuan MALAYSIA | 03/26/2019 | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Royal Honey | Royal Honey | Royal Honey | Royal Honey | Royal Honey | Royal Honey | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | Royal Honey; Note: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 4/01/2019 | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. |
| Medcare Smart SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 21-1 Jalan kg Pandan , Taman Maluri 55100 , Kuala, Lampur MALAYSIA | 09/22/2016 | 36 C - - 04 Honey | 66 S - - 51 Tadalafil | Golden Royal Honey | Golden Royal Honey | Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil |
| Natural Elixirs | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 6 Jalan Jasmin , Selangor, MALAYSIA | 05/04/2017 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | GRANDE PLATINUM - BINDII | Ultra Detox Capsules | Ultra Detox Capsules | GRANDE PLATINUM - BINDII | Ultra Detox Capsules | Product was found to contain undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil | Product was found to contain undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil |
| NATURAL ELIXIRS SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | No 17 Jalan Selat Selat , Pelabuhan Klang, MALAYSIA | 11/27/2018 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Ultra Detox Capsules | Ultra Detox Capsules | Ultra Detox Capsules | FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil |
| SUPERFOOD INTERNATIONAL SDN BHD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | Lot 23 Prai Industrial , Penang, MALAYSIA | 01/31/2022 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | VITAMAX DOUBLESHOT Energy Honey | VITAMAX DOUBLESHOT Energy Honey | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. |
| Worldgate Vision Beverage Sdn Bhd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | Kawasan Perusahaan Sungai Tukang , 95 Lorong Enggang 6 , Kuala Muda, Kedah MALAYSIA | 08/05/2016 | 31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts) | 31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts) | 31 - - - -- Coffee/Tea | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 99 Regulator N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | STIFF BULL HERBAL COFFEE | Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | STIFF BULL HERBAL COFFEE | Natural Herbs Coffee | Product was found to contain undeclared Desmethyl carbodenafil | Product was found to contain undeclared Desmethyl carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Product was found to contain undeclared Desmethyl carbodenafil | Product was found to contain undeclared Desmethyl carbodenafil. |
| Yong Fatt Vision T | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 16 A431 Lorong , Sungai Petani, Kedah MALAYSIA | 09/19/2017 | 31 - - - -- Coffee/Tea | 54 F - - -- Herbal & Botanicals(other than teas) | 65 P - - 02 Sildenafil Citrate (Regulator) | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; |
| Yongfatt Vision Tr | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MALAYSIA | 95 Jalan Enggang , Sungai Petani, Kedah MALAYSIA | 09/19/2017 | 31 - - - -- Coffee/Tea | 54 F - - -- Herbal & Botanicals(other than teas) | 65 P - - 02 Sildenafil Citrate (Regulator) | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; ; 9/18/2017 | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; |
| Pharmacy International, Inc. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MALAYSIA | Jln Bk 4/1l , Kuala Lumpur, Wilayah Persekutuan MALAYSIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 |
| Baja Fur S A De C V | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Romano 1352 , Tijuana, MEXICO | 02/02/2010 | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | ALl Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 |
| Christian Cosmetics | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Ensenada #394, Sec. Triangulo De , Tijuana, MEXICO | 06/18/2014 | 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Christian Eyebrow makeup Bronzed | Christian Eyebrow makeup Charcoal | Christian Eyebrow makeup black | Eyebrow Make Up Kits | 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 | 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 | 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 | 601(a); Organisms recovered include Gram negative Pseudomonas oryzihabitans; Gram negative Pantoea spp; Gram positive rods; Gram negative Sphingomonas paucimobilis; Gram positive; Micrococcus spp; Oxidase positive; non-lactose fermenting and Gram positive spore forming bacillus; Pseudomonas Stutzeri; Sphingomonas paucimobilis; S. epidermidis; S. hominis; S. warneri; Serratia fonticola; Yeast and Mold. Published on 05/21/2012 |
| Comercial Urania Sa De Cv | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Saltillo No 119 , Col. Hipodromo, Cuauhtemoc , Ciudad De Mexico, Ciudad de Mexico MEXICO | 05/29/2012 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Moisturizing Cream | Moisturizing Cream | Moisturizing Cream | Moisturizing Cream | B.Cepacian | B.Cepacian | B.Cepacian | B.Cepacian |
| Commercializadora Intergral Belleza Sa Cv | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Ticoman No14 Tepeyac Insurgentes , Mexico City, MEXICO | 04/20/2012 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Mascara with Avocado oil | 601(a) Enterococcus faecium |
| Cosmetobellezas Natural S.A De C.V. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Martin Luis Guzman 215 , Colonia Iztaccihuatl , Benito Juarez, Ciudad de Mexico MEXICO | 09/18/2009 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Mascara w/mamey seed oil;7/15/03 | 601(a); gram negative rods |
| Dermatisse Cosmeticos S.A. De C.V. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Avenida San Jeronimo 506-A , Col. TORRES DE SAN JERONIMO , Monterrey, Nuevo Leon MEXICO | 03/14/2011 | 53 C - - 02 Eyeliner (Eye Makeup Preparations) | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 G - - 05 Lipstick (Makeup Preparations, not for Eyes) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Eyeshadow Compact Dermatisse Brand | Eyeshadow Compact Dermatisse Brand | Eyeshadow Compact Dermatisse Brand | Eyeshadow Compact Dermatisse Brand | 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens | 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens | 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens | 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens |
| Framesi Laboratorios, S.A. de C.V. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Miguel Cruz Afdo., No. 10-B , Col. Flores Magon , Mexico, D.F. MEXICO | 09/18/2009 | 53 C - - 06 Mascara (Eye Makeup Preparations) | 53 C - - 06 Mascara (Eye Makeup Preparations) | Mascara with mamey seed oil; 9/4/03 | Mascara w/avocado oil; 5/5/04 | 601(c); multiple micro contaminants & non-fermentative gram negative rods and gram positive rods with spores | ENTEROBACTER : CLOACAE; | 601(a) | ENTEROBACTER : CLOACAE; PSEUDOMONAS : AERUGINOSA; LECLERCIA : ADECARBOXYLATA; KLEBSIELLA : PNEUMONIAE; |
| Industrializadora de Cacahuananche, S.A. de C.V. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Camino Arenero No. 20 , Col. San Juan De Ocotan, Zapopan , Zapopan, Jalisco MEXICO | 10/12/2017 | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | Shampoo Herbal Bear Oil Aceite de Oso | Problem(s); Pseudomonas Aeruginosa |
| Laboratorios Naturamex | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Morelos Sur 899 , Col. Ventura Puente , Morelia, Michoacan MEXICO | 09/18/2009 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Avocado seed oil & mamey seed oil; 3/25/04 | multiple micro contaminants including yeast/mold; gram positive rods; gram negative rods | STAPHYLOCOCCUS; CHRYSEOMONAS : LUTEOLA; |
| MEGAMIX | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Antonio Alzate #71 Int. "A" Centro , Morelia, MEXICO | 09/18/2009 | 53 C - - 06 Mascara (Eye Makeup Preparations) | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | Mascara | Mascara; 5/10/05 | Mascara;5/10/05 | 5/10/05 |
| NATRA BAY SA DE CV | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Benito Juarez S/N Loc 2 Ent. Cjon , Col. CENTRO , Loreto, Baja California sur MEXICO | 12/02/2013 | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | Moringa Oil | Powdered Moringa Root | Charge -- Yeast/mold | Charge -- Kleibseilla pneumonia |
| Probelco S.A. de D.V. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Biznaga No. 43 , Col. Las Palmas, Alvaro Obregon , Ciudad De Mexico, Ciudad de Mexico MEXICO | 09/18/2009 | 53 C - - 02 Eyeliner (Eye Makeup Preparations) | 7/25/08 | 601(a) | PSEUDOMONAS : PUTIDA; |
| Prosa Productos Naturales, S.A. de C.V. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | 4a Cerrada Sur 57 174 , Mexico, DF MEXICO | 09/18/2009 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Mascara w/mamey seed oil;9/23/03 | 601(a); gram positive and gram negative bacilli |
| REJUVENTUM, SA DE CV | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MEXICO | Calle Zaragoza No 1 , Colonia Cuajimalpa , Cuajimalpa De Morelos, Ciudad de Mexico MEXICO | 12/17/2013 | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | Hydrating Toner | CHARGE/CONTAMINANT -- 601(a); B. vallisomortis and E. gergoviae |
| ASESORIA Y DESARROLLO DE PRODUCTOS NATURALES | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Avenida Mexico #3300 D-14, Monraz , Jalisco , Guadalajara, MEXICO | 07/29/2024 | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | UMARY Acido Hialuronico | UMARY Acido Hialuronico | UMARY Acido Hialuronico | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Avenida Patria 288-1 , Col. Jardines De La Patria, Zapopan , Zapopan, Jalisco MEXICO | 07/29/2024 | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | UMARY Acido Hialuronico | UMARY Acido Hialuronico | UMARY Acido Hialuronico | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole |
| EREN NATURALS SA DE CV | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Calle Tepame Paraisos De 1518 , Col. Paraisos Del Colli, Zapopan , Zapopan, Jalisco MEXICO | 06/17/2025 | 54 K - - 14 Glucosamine Hydrochloride (Herbal and Botanicals, not Teas II) | 54 K - - 14 Glucosamine Hydrochloride (Herbal and Botanicals, not Teas II) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | UMOVY Acido Hialuronico Suplemento Alimenticio | UNAVY Acido Hialuronico Suplemento Alimenticio | UNAVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | UMOVY Acido Hialuronico Suplemento Alimenticio | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | UNAVY Acido Hialuronico Suplemento Alimenticio FDA laboratory analysis confirmed the product contains undeclared diclofenac, omeprazole and dexamethasone phosphate. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone phosphate. |
| ESPECIALIDADES NUTRITION SA DE C | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Avenida Patria Jardi 288 , Col. Jardines De La Patria, Zapopan , Zapopan, Jalisco MEXICO | 07/29/2024 | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | UMARY Acido Hialuronico | UMARY Acido Hialuronico | UMARY Acido Hialuronico | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. |
| GRUPO BOTANICO NAYEC SA DE CV | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Espana 423 , Col. San Juan Xalpa, Iztapalapa , Ciudad De Mexico, Ciudad de Mexico MEXICO | 02/04/2016 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Tepezcohuite Capsules | Tepezcohuite Capsules | Tepezcohuite Capsules | Tepezcohuite Capsules | Tepezcohuite Capsules | Product was found to contain undeclared N; N- Dimethyltryptamine | Product was found to contain undeclared N; N- Dimethyltryptamine | Product was found to contain undeclared N; N- Dimethyltryptamine | Product was found to contain undeclared N; N- Dimethyltryptamine | Product was found to contain undeclared N; N- Dimethyltryptamine |
| Healthy People Labs S de RL de CV | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | PROL. ALVARO OBREGON # 961 , COL. LOS HOYOS , Irapuato, Guanajuato MEXICO | 01/25/2018 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin) | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil |
| Healthy People S de R.L. de CV | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Calle Luis Alcantara No. 674 , Col. Los Eucaliptos , Irapuato, Guanajuato MEXICO | 01/25/2018 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin) | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Goji-Man Mangosteen Liquid Dietary Supplement | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil | Problem(s); Sildenafil |
| Herbolaris Internacional | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Paseo Los Robles 122 , Fraccionamiento Valle De San Isidro , Zapopan, Jalisco MEXICO | 01/24/2018 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 54 Y - - 09 Germanium (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | CBC Dietary Supplement | CBC Dietary Supplement | CBC Dietary Supplement | CBC Dietary Supplement | CBC Dietary Supplement | CBC Dietary Supplement | CBC Dietary Supplement | CBC Dietary Supplement | Problem(s); Product was found to contain undeclared Norepinephrine | Problem(s); Product was found to contain undeclared Norepinephrine | Problem(s); Product was found to contain undeclared Norepinephrine | Problem(s); Product was found to contain undeclared Norepinephrine | Problem(s); Product was found to contain undeclared Norepinephrine | Problem(s); Product was found to contain undeclared Norepinephrine | Problem(s); Product was found to contain undeclared Norepinephrine | Problem(s); Product was found to contain undeclared Norepinephrine |
| LAB NAPROVID | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Vixtor Estrella 100 , Sonora, COL MEXICO | 06/22/2026 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Contra Reumas Suplemento Alimenticio (Against Rheumatism Dietary Supplement) | Contra Reumas Suplemento Alimenticio (Against Rheumatism Dietary Supplement) | Contra Reumas Suplemento Alimenticio (Against Rheumatism Dietary Supplement) | Contra Reumas Suplemento Alimenticio (Against Rheumatism Dietary Supplement) | Contra Reumas Suplemento Alimenticio (Against Rheumatism Dietary Supplement) | FDA laboratory analysis confirmed the product contains undeclared Diclofenac, Dexamethasone and Methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared Diclofenac, Dexamethasone and Methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared Diclofenac, Dexamethasone and Methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared Diclofenac, Dexamethasone and Methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared Diclofenac, Dexamethasone and Methocarbamol. |
| OMEGA NUTRITION | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Jorge Washington No 108 , Hidalgo Del Parral, MEXICO | 07/11/2022 | 54 A - - 99 Vitamin, N.E.C. | 54 K - - 14 Glucosamine Hydrochloride (Herbal and Botanicals, not Teas II) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 G - - 18 Diclofenac Sodium (Anti-Inflammatory) | 62 G - - 18 Diclofenac Sodium (Anti-Inflammatory) | 62 G - - 90 Diclofenac Potassium (Anti-Inflammatory) | 62 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 C - - 99 Nutrient/Tonic N.E.C. | 65 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Artrifan King | Force Forever | Artrifan King | Force Forever | Ortiga mas Ajo Rey Extra Forte | Ortiga mas Ajo Rey Extra Forte | Ortiga mas Ajo Rey Extra Forte | Ortiga mas Ajo Rey Extra Forte | Ortiga mas Ajo Rey Extra Forte | Ortiga mas Ajo Rey Extra Forte | Artrifan King | Force Forever | Artrifan King | Ortiga mas Ajo Rey Extra Forte | Ortiga mas Ajo Rey Extra Forte | Ortiga mas Ajo Rey Extra Forte | Force Forever | Ortiga mas Ajo Rey Extra Forte | Force Forever | Artrifan King | Ortiga mas Ajo Rey Extra Forte | FDA laboratory analysis confirmed the product contains undeclared diclofenac, dexamethasone, and methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone. | FDA laboratory analysis confirmed the product contains undeclared diclofenac, dexamethasone, and methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared diclofenac, dexamethasone, and methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone. | FDA laboratory analysis confirmed the product contains undeclared diclofenac, dexamethasone, and methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. | FDA laboratory analysis confirmed the product contains undeclared diclofenac and dexamethasone. | FDA laboratory analysis confirmed the product contains undeclared diclofenac, dexamethasone, and methocarbamol. | Ortiga mas Ajo Rey Reforzado con Omega 3; 6; y 9 FDA laboratory analysis confirmed product contains undeclared Diclofenac. | FDA laboratory analysis confirmed product contains undeclared Diclofenac, Dexamethasone, and Methocarbamol. |
| PLANTAS HERBOLARIAS DE MEXICO | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | Avenida Ignacio Zaragoz , Santa Ana, MEXICO | 07/07/2023 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | AK Forte; FDA laboratory analysis confirmed product contains undeclared diclofenac, dexamethasone, and methocarbamol. | |
| PLANTAS MEDICINALES DE MEXICO | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | MEXICO | MELCHOR OCAMPO 55 LOCAL D , DELEGACION XOCHIMILCO C.P, MEXICO | 06/08/2022 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | AArtri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | Artri Ajo King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac.; Artri King Reforzado con Ortiga y Omega 3; NOTE: FDA laboratory analysis confirmed product contains undeclared Diclofenac and Dexamethasone. | |
| Azteca Trio International S A De C V | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Blve Cuauhtemoc 118-2 Suite 416 , Zona Rio Tijuana, B C MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | |
| Baja Triado Internacional S A de C V | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Blvd Cuauhtemoc 118-2 Suite 416 , Zona Rio Tijuana, B C MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | All prescription drugs 4/16/1993 NOTE: Baja Triado Internacional, SA, Mexico, appears to be a new name for Azteca Trio Internacional, SA de CV, Mexico. | |
| CORNE S A de C V | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Rio San Lorenzo No 623 , Col Puentes del Valle , Garza Garcia, Nuevo Leon MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | Beta-interferon (Alternate names - Rebif, R-FRONE) 11/1/1993 San-DO received promotional literature for the purchase of this product. Teh literature identifies the product for hte treatment of multiple sclerosis and implies it is similar to the approved interferon beta-1b apporved for use in hte US. The product is shipped via UPS upon receipt of a docotr's prescription. The shipment includes FRONE 3,000,000 U.I. with diluent, etc., for $200. Information from the manufacturerof the approved Beta-Interferon to be sold int he US, indicates this productapppears to behalf the strenthof the US recommended therapeutic dose. | |
| CS Distribuidora S.A. de C.V. (Main Office) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Calle Cordoba # 138 , Col. Roma Norte, Cuauhtemoc , Ciudad De Mexico, Ciudad de Mexico MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 |
| CS Distribuidora S.A. de C.V. (Plant) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Av. De La Carretera No. 1335 , Zona Industrial Irapuato (Ciudad Industrial), Irapuato , Irapuato, Guanajuato MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 |
| Farmacias Fantini | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | 20 de Noviembre 109 , Cuautitlan, Edo MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . |
| Innovaciones Medicas S A De C V aka Innomed-Mex | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Protasio Tangle No 132 A y B , Colonia San Miguel , Chapultepec, D F MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 10/3/1995 | All prescription drugs 10/3/1995 | All prescription drugs 10/3/1995 | All prescription drugs 10/3/1995 | All prescription drugs 10/3/1995 | All prescription drugs 10/3/1995 | All prescription drugs 10/3/1995 | All prescription drugs 10/3/1995 | |
| JFW Enterprises (John William) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Angel Garcia Aburto #364 , Co. Balderama , Hermosillo, SON MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 |
| Mercantil Farmaceutica Patria | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Newton 104 Col Polanco , Mexico, MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | |
| Rx World | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Tepayac 2313 Oriente , Colonia Hidalgo , Juarez, Chihuahua MEXICO | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 12/19/1997 | All prescription drugs 12/19/1997 | All prescription drugs 12/19/1997 | All prescription drugs 12/19/1997 | All prescription drugs 12/19/1997 | All prescription drugs 12/19/1997 | All prescription drugs 12/19/1997 | All prescription drugs 12/19/1997 |
| RXMEX-Com SA de CV | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | MEXICO | Avenida Lazaro Cardenas # 4207 , Colonia Las Brisas 10 Sector , Monterrey, Nuevo Leon MEXICO | 09/10/2009 | 65 P - - 02 Sildenafil Citrate (Regulator) | Zenegra (Sildenafil Citrate 100 mg. oral tablets) | 8/20/2003 |
| Laboratorios Tornel, S.A. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | MEXICO | Venusiano Carranza No. 24 , Naucalpan, MEXICO | 03/01/2018 | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 67 - - - -- Type A Medicated Articles | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | 68 - - - -- Animal Devices and Diagnostic Products | Ca-Aminoplex | Enfloxil | K-Ton 12 | Antoplex | Coccizuril | Super Amin-toplex Gallos | Top B15 3 | Pangamine | Super Flumi-Strep | Coccizuril | Ca-Aminoplex | Antoplex | Super Flumi-Strep | Super Amin-toplex Gallos | Pangamine | Enfloxil | Top B15 3 | K-Ton 12 | Ca-Aminoplex | Antoplex | Enfloxil | Top B15 3 | Coccizuril | Pangamine | K-Ton 12 | Super Flumi-Strep | Super Amin-toplex Gallos | Coccizuril | Top B15 3 | Ca-Aminoplex | Enfloxil | K-Ton 12 | Super Amin-toplex Gallos | Antoplex | Super Flumi-Strep | Pangamine | Top B15 3 | Ca-Aminoplex | Coccizuril | Enfloxil | K-Ton 12 | Pangamine | Super Flumi-Strep | Antoplex | Super Amin-toplex Gallos | |
| Lebssa Sa De Cv | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | MEXICO | Avenida Las Juventudes 13284c , Fraccionamiento El Lienzo , Mexicali, Baja California MEXICO | 06/09/2015 | 54 A - - 01 Vitamin A | 54 A - - 14 Vit D | 54 A - - 16 Vitamin E (Tocopherol) | 54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin) | MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D) | MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D) | MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D) | MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D) | |
| Parfarm Sa | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | MEXICO | Aragon 25 Col , Alamos, MEXICO | 07/16/2026 | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 C - - 99 Nutrient/Tonic N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | ARSIL | ARSIL | ARSIL | ARSIL | ARSIL | |
| Zirin Laboratories De | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | MEXICO | Calle Rio Yapura No. 149 , Colonia Argentina Poniente , Miguel Hidalgo, Ciudad de Mexico MEXICO | 07/16/2026 | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 C - - 99 Nutrient/Tonic N.E.C. | 65 R - - 99 Replenisher N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | CARDIO BEE 15 | CARDIO BEE 15 | CARDIO BEE 15 | CARDIO BEE 15 | CARDIO BEE 15 | CARDIO BEE 15 | |
| Lesieur Cristal | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | MOROCCO | 1 Rue Caporal Branly , Casablanca, MOROCCO | 07/25/2011 | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | Soap 100% Clay | Soap 100% Clay | 601(a) Pseudomonas Stutzeri Cronobacter spp. Acinetobacter radiocresistens | 601(a) Pseudomonas Stutzeri Cronobacter spp. Acinetobacter radiocresistens; 7/26/2011 |
| ALP Food Supplements (aka J H Agelink) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NETHERLANDS | De Wittenkade 1221 , Amsterdam, Noord-Holland NETHERLANDS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | All prescription drugs 6/6/1996 Promorional solicitations for purchasing foreign versions of apporved US prescription drugs. These firms have been identified as shippers for orders made through Euro Care Mailorder Pharmacywhich is also on DWPE inder IA# 66- 57. ALP Foods Supplements (aka J.H. Agelink) has also been identified as soliciting individuals through the World Wide Web (Internet). | |
| Euro Care Mail Order Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NETHERLANDS | 8200 AB , Postbus 78 , Lelystad, Flevoland NETHERLANDS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 4/16/1996 | All prescription drugs 4/16/1996 | All prescription drugs 4/16/1996 | All prescription drugs 4/16/1996 | All prescription drugs 4/16/1996 | All prescription drugs 4/16/1996 | All prescription drugs 4/16/1996 | All prescription drugs 4/16/1996 | |
| F J M Borking | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NETHERLANDS | Dodaarslaan 90 , Vinkeveen, Utrecht NETHERLANDS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; All prescription drugs; 9/29/1992 | |
| P Goudvis (aka Afz. Fisher) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NETHERLANDS | Pm 8243 , Vijzelweg 32 , Lelystad, Flevoland NETHERLANDS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | All preseciption drugs 4/16/1996 and 6/6/1996 Afz. Fisher has been identified as an alternate name used on packages shipped by P. Goudvis, Netherlands. | |
| Spank Products | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NETHERLANDS | unknown , Amsterdam, NETHERLANDS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 | All Prescription Drugs; 8/9/2001 |
| Unknown Name of shipper | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NETHERLANDS | P O Box 70385 , Amsterdam, Holland NETHERLANDS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| Belgica De Weerd, B.V. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | NETHERLANDS | Van De Reijtstraat 21 , Breda, Noord-Brabant NETHERLANDS | 10/17/2016 | 54 A - - 01 Vitamin A | 54 A - - 01 Vitamin A | 54 A - - 01 Vitamin A | 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 03 Vitamin B2 (Riboflavin) | 54 A - - 03 Vitamin B2 (Riboflavin) | 54 A - - 06 Niacin (Nicotinic Acid) (Vitamin) | 54 A - - 13 Vitamin C (Ascorbic Acid) | 54 A - - 14 Vit D | 54 A - - 14 Vit D | 54 A - - 14 Vit D | 54 A - - 14 Vit D | 54 A - - 14 Vit D | 54 A - - 16 Vitamin E (Tocopherol) | 54 A - - 16 Vitamin E (Tocopherol) | 54 A - - 22 Sodium Ascorbate (Vitamin) | 54 A - - 22 Sodium Ascorbate (Vitamin) | 54 A - - 99 Vitamin, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | BelgaFox | Belga Coxi | Belga White | B.S. Tablets [oral veterinary medicine] | 4 in 1 Mix | Belga Magix | Belgamco | BelgaBac | Belga Tai[marketed as Veterinary Medicine] | W.N. Red | W.N. Black | Belgaroni 10% [Veterinary Medicine] | BelgaSun | Parastop [Veterinary medicine] | Essential Oil Belgica | Cobel [Veterinary Medicine] | OrniSpecial Extra [Veterinary Medicine] | Belga Drops | BelgaBion | BelgaWormac [marketed as Veterinary Medicine] | |
| AIRPORT OAK PHARMACY | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | 491 NEW NORTH RD , KINGSLAND , AUCKLAND, NEW ZEALAND | 09/10/2009 | 60 R - - 99 Anorexic, N.E.C. | Xenical 8/4/1999 | |
| Albany Street Pharmacy, Ltd (aka onlinepharmcy) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | PO Box 6104 , Dunedin, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | |
| Cipro Antibiotics Network (D Manager) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | 41 Cedar Avenue , Cedar House , Hamilton, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 |
| Cox's Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | Crn Mayfair and Line Roads , Glen Innes, NEW ZEALAND | 09/10/2009 | 60 R - - 99 Anorexic, N.E.C. | Xenical | 8/4/1999 |
| Hair2Go (aka Kerry Bell) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | Kingsland , PO Box 52173 , Auckland, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 | All prescription drugs 3/22/2000 |
| Hampstead Trust (aka Pharmcom International) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | 326 Sunset Road , Auckland, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 ;The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Mens Pharmacy (aka Ink Electronic Media Ltd.) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | 1 River Road RD. , Hamilton, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000; (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy- geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy- geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy- geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy- geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy- geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy- geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) |
| Mp & Je Gould | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | Po Box 18091 , Auckland, NEW ZEALAND | 09/10/2009 | 60 R - - 99 Anorexic, N.E.C. | Xenical | 8/4/1999 |
| Pharmacy-geoff (aka INK Electronic Media, Ltd.) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | River Road, R.D. 1 , Hamilton, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) |
| Planet Drugs Direct | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | P.O. 105-290 , Auckland, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 11/25/2001 | All Prescription Drugs; 11/25/2001 | All Prescription Drugs; 11/25/2001 | All Prescription Drugs; 11/25/2001 | All Prescription Drugs; 11/25/2001 | All Prescription Drugs; 11/25/2001 | All Prescription Drugs; 11/25/2001 | All Prescription Drugs; 11/25/2001 |
| Ten Valde, John | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | Leith PLace , Tokoroa, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 |
| United Pharmacies (aka INK Electronic Media, Ltd.) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | NEW ZEALAND | River Road, R.D. 1 , Hamilton, NEW ZEALAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) | Notes:All prescription drugs - 3/14/2000 (aka menspharmacy.com) (aka pharmacy-geoff.com) (aka unitedpharmacies.com) (aka slimmerspharmacy.com) (aka hairpharmacy.com) (aka lifepharmacy.com) (aka smokerspharmacy.com) |
| Honey Collection Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | NEW ZEALAND | 69 Grove Road , Mayfield , Blenheim , Marlborough NEW ZEALAND | 06/06/2018 | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Pet Magic UMF Manuka Honey Cream | Pet Magic UMF Manuka Honey Cream | Pet Magic UMF Manuka Honey Cream | |
| South Pacific Sera Limited | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | NEW ZEALAND | 26 Kennels Road , R D 4 , Timaru, NEW ZEALAND | 12/10/2014 | 68 L - - 99 Disposable/Sigle Use Devices, NEC (Nonhuman) | 68 M - - 03 Cages, including oxygen cages (Nonhuman) | 68 M - - 07 Hematology Analyzer (Nonhuman) | 68 Z - - 99 Animal Medical Devices, NEC | Ovagen - Follicle Stimulating Hormone (FSH) | Ovagen - Follicle Stimulating Hormone (FSH) | Ovagen - Follicle Stimulating Hormone (FSH) | Ovagen - Follicle Stimulating Hormone (FSH) | |
| M/S Taimoor Enterprises | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | PAKISTAN | Flat # 28-29 2nd Floor P.m.c Khybar , Peshawar, PAKISTAN | 09/18/2009 | 53 C - - 02 Eyeliner (Eye Makeup Preparations) | Surma; eye liner; black powder; 1/23/07 | 601(a); 601(c); a variety of microbes present; yeast and mold; Sphinomonas paucimoblis; M. haemolytica | STAPHYLOCOCCUS : AUREUS; ESCHERICHIA : COLI (TYPICAL); |
| Mm Laboratories | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | PAKISTAN | Hafizabad Rd , Gujranwala, PAKISTAN | 03/27/2015 | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | Ashe Nu Face Cream | Problem(s); Mold Escherichia coli Gram-negative organisms; including opportunistic pathogens |
| PRODUCTOS JUMAM EIRL | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | PERU | Av Bolivia No 1014 , Brena, Lima PERU | 09/18/2009 | 53 L - - 99 Other Skin Care Preparations, N.E.C. | Baba de Caracol Skin Cream | shipper; 8/3/07; PSEUDOMONAS ; AERUGINOSA; |
| Sandoval Drugs (I-Mart) c/o James Sandoval | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | PHILIPPINES | 84 Solmac Bldg., Suite 310-311 , Dapitan Corner Banawe Sts. , Quezon City, PHILIPPINES | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 |
| ENSON LABORATORIES, INC. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | PHILIPPINES | Phoenix Road , Meycauayan, Central Luzon PHILIPPINES | 07/26/2019 | 56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Amoxicillin Trihydrate Tylosin Tartrare Bromehexine Hydroclhloride; (Derbimox); 100 g/100 g/3 g; Water Soluble Powder Antibacterial/Mucolytic | Lincomycin HCl Spectinomycin HCl Bromhexine; 100 mg/50 mg/2.5 mg per ml Solution for Injection (IM) Antibacterial | |
| EXCELLENCE POULTRY & LIVESTO | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | PHILIPPINES | 6th Floor, The Spark Pl , Quezon, PHILIPPINES | 08/07/2019 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | |
| Premium Lab | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | PHILIPPINES | 498 M.H. Del Pilar St. , Rizal, PHILIPPINES | 12/05/2016 | 60 W - - 26 Piperazine (Anthelmintic) | 60 W - - 99 Anthelmintic, N.E.C. | Wormal Tablets | Wormal Tablets | |
| C WORLD KSG CORPORATION | 86-11 | "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination" | PHILIPPINES | NO 2 8th Street Golden Mile Business Par , Cavite, Calabarzon PHILIPPINES | 11/19/2015 | 86 L - - PL Lenses, Soft Contact, Daily Wear | Contact lenses | All brands of contact lenses are subject to DWPE. |
| RICHARD KIM | 86-11 | "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination" | PHILIPPINES | The Levels Com , Cavite, Calabarzon PHILIPPINES | 11/29/2016 | 86 L - - PL Lenses, Soft Contact, Daily Wear | Contact lenses | All brands of contact lenses are subject to DWPE. |
| Pharma Group | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | PORTUGAL | Avenida Antonio Augusto de Aguiar 17B , Suite 6 , Lisbon, Lisboa PORTUGAL | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 |
| Lvmh Fragranc Cosmetics | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | SINGAPORE | 31 Jurong Port Rd , Jurong Logistics Hub, SINGAPORE | 04/11/2012 | 53 C - - 06 Mascara (Eye Makeup Preparations) | Mascara (Fresh Supernova) | 601(a) Enterococcus casseliflavus; Microccus luteus and Staphylococcus lentus |
| #1 Drugstore Online (John Wong) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SINGAPORE | P.O. Box 115 , Singapore, SINGAPORE | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 7/31/2001 | All prescription drugs; 7/31/2001 | All prescription drugs; 7/31/2001 | All prescription drugs; 7/31/2001 | All prescription drugs; 7/31/2001 | All prescription drugs; 7/31/2001 | All prescription drugs; 7/31/2001 | All prescription drugs; 7/31/2001 | |
| Netzah Pharmacy Co | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SINGAPORE | 115 Airport Cargo Road , #02-20 Cargo Agents Building C , Singapore, SINGAPORE | 04/18/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic) | 60 T - - 15 Naltrexone (Antagonist) | Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules | |
| Bee Natural | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | SOUTH AFRICA | Plot 191 Canyon , Randvaal, Gauteng SOUTH AFRICA | 09/14/2016 | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | Living Clay Face Mask | Living Clay Face Mask | CANDIDA PARAPSILOSIS; KLUYVERA INTERMEDIA; AEROMONAS SPP. | ENTEROBACTER : ASBURIAE; ENTEROBACTER : CLOACAE; ESCHERICHIA : COLI (TYPICAL); KLEBSIELLA : OXYTOCA; KLEBSIELLA : PNEUMONIAE SUBSP. PNEUMONIAE; KLUYVERA : CRYOCRESCENS; PSEUDOMONAS : PUTIDA; | CANDIDA PARAPSILOSIS; KLUYVERA INTERMEDIA; AEROMONAS SPP. | ENTEROBACTER : ASBURIAE; ENTEROBACTER : CLOACAE; ESCHERICHIA : COLI (TYPICAL); KLEBSIELLA : OXYTOCA; KLEBSIELLA : PNEUMONIAE SUBSP. PNEUMONIAE; KLUYVERA : CRYOCRESCENS; PSEUDOMONAS : PUTIDA; |
| Alants (aka Jansen van Vuuren) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SOUTH AFRICA | 8A Howe Circle , Homestead , Germiston, Gauteng SOUTH AFRICA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 3/22/2000 | All Prescription Drugs ; 3/22/2000 | All Prescription Drugs ; 3/22/2000 | All Prescription Drugs ; 3/22/2000 | All Prescription Drugs ; 3/22/2000 | All Prescription Drugs ; 3/22/2000 | All Prescription Drugs ; 3/22/2000 | All Prescription Drugs ; 3/22/2000 |
| Jansen van Vuuren (aka alants) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SOUTH AFRICA | 8A Howe Circle , Homestead , Germiston, Gauteng SOUTH AFRICA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 3/22/2000 | All Prescription Drugs; 3/22/2000 | All Prescription Drugs; 3/22/2000 | All Prescription Drugs; 3/22/2000 | All Prescription Drugs; 3/22/2000 | All Prescription Drugs; 3/22/2000 | All Prescription Drugs; 3/22/2000 | All Prescription Drugs; 3/22/2000 |
| The Somatropin Drugstore | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SOUTH AFRICA | 36 Adderly Street , Cape Town, SOUTH AFRICA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | All prescription drugs; 3/27/01 | |
| Afriplex (Pty) Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SOUTH AFRICA | 10 De Vreugde Crescent , Paarl, Western Cape SOUTH AFRICA | 10/19/2016 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 61 X - - 99 Anti-Histaminic N.E.C. | 61 X - - 99 Anti-Histaminic N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Regal Skin Care Remedy | Regal Joint Health Remedy | Regal Skin Care Combo | Regal Glossy Coat Remedy | Regal Skin Care Combo | Regal Skin Care Remedy | Regal Joint Health Remedy | Regal Glossy Coat Remedy | |
| HERBEX PTY LIMITED | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SOUTH AFRICA | Unit 2 , Nexus Place , Cape Town, Western Cape SOUTH AFRICA | 10/19/2016 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 61 X - - 99 Anti-Histaminic N.E.C. | 61 X - - 99 Anti-Histaminic N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Regal Glossy Coat Remedy | Regal Skin Care Combo | Regal Joint Health Remedy | Regal Skin Care Remedy | Regal Skin Care Combo | Regal Skin Care Remedy | Regal Joint Health Remedy | Regal Glossy Coat Remedy | |
| OPHTHALMICA PTY LTD | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SOUTH AFRICA | Park Bldg , 101 Albert Road , Centurion, Gauteng SOUTH AFRICA | 07/10/2025 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 Z - - 99 Animal Medical Devices, NEC | 86 M - - OE Collagen Corneal Shield | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | |
| Southern Implants, (Pty.) Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SOUTH AFRICA | One Albert Road , Irene, Gauteng, SOUTH AFRICA | 07/10/2025 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 Z - - 99 Animal Medical Devices, NEC | 86 M - - OE Collagen Corneal Shield | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | |
| SOUTHERN MEDICAL (PTY) LTD | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SOUTH AFRICA | 55 Regency, Route 21 Corporate Park, Irene, Pretoria , Irene, Gauteng SOUTH AFRICA | 07/10/2025 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 65 N - - 67 Sodium Rose Bengal I 125 (Radioactive Agent) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 Z - - 99 Animal Medical Devices, NEC | 86 M - - OE Collagen Corneal Shield | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | |
| BEAUNIVATIONS SL | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | SPAIN | Placa Vapor 11 12c , Badalona, Barcelona SPAIN | 04/20/2026 | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 14 Eyelash and Eyebrow Treatments-Gel, Oil, Primer, Conditioners, Serum, Fortifiers (Eye Makeup Prepara | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | Filling Anti-Wrinkle Lift Syringe | Filling Anti-Wrinkle Lift Syringe | Filling Anti-Wrinkle Lift Syringe | Filling Anti-Wrinkle Lift Syringe | Filling Anti-Wrinkle Lift Syringe | 601(a) Gram-Positive cocci; Aerococcus viridans. | 601(a) Gram-Positive cocci; Aerococcus viridans. | 601(a) Gram-Positive cocci; Aerococcus viridans. | 601(a) Gram-Positive cocci; Aerococcus viridans. | 601(a) Gram-Positive cocci; Aerococcus viridans. |
| Libertarian Solutions (c/o Mr. Dennis Faulkner) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SPAIN | Nogal No. 7 , Torreblanca Fuengirola , Malaga, SPAIN | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/27/01 | All prescription drugs; 3/27/2001 | All prescription drugs; 3/27/2001 | All prescription drugs; 3/27/2001 | All prescription drugs; 3/27/2001 | All prescription drugs; 3/27/2001 | All prescription drugs; 3/27/2001 | All prescription drugs; 3/27/2001 |
| Mail Pack Ship, S.L. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SPAIN | Av De Las Naciones Unidas 43 , Puerto Banus, SPAIN | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug Products;11/12/1999 | All Drug Products;11/12/1999 | All Drug Products;11/12/1999 | All Drug Products;11/12/1999 | All Drug Products;11/12/1999 | All Drug Products;11/12/1999 | All Drug Products;11/12/1999 | All Drug Products;11/12/1999 | |
| WineDirect.net (Jorge Galet) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SPAIN | Calle Gomez Becerra 18 11d , Caceres, Caceres SPAIN | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | All prescription drugs; 2/19/2002 | |
| Laboratorios Calier, S.A. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SPAIN | Parc Empresarial Mas Blau Ii C/ , Barcelona, SPAIN | 08/07/2019 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) | |
| Enzymatica AB | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SWEDEN | Forskningsbyn Ideon , Ideon Science Park , Lund, Skane Lan SWEDEN | 03/13/2015 | 61 W - - -- A-Fungal | 62 F - - -- A-Infective, Topical | 62 G - - -- A-Inflammatory | 62 G - - -- A-Inflammatory | 62 G - - -- A-Inflammatory | 62 S - - -- A-Seborrheic | 63 R - - -- Dental Caries Prophyl | 63 R - - -- Dental Caries Prophyl | 63 S - - -- Dental Protect | 63 S - - -- Dental Protect | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 R - - -- Dental-Nonhuman | 68 R - - -- Dental-Nonhuman | Kalvatin Dermal Gel | Kalvatin Dermal Gel | Kalvatin Dental Gel | Kalvatin Dental Spray | Kalvatin Dermal Gel | Kalvatin Dermal Gel | Kalvatin Dental Spray | Kalvatin Dental Gel | Kalvatin Dental Spray | Kalvatin Dental Gel | Kalvatin Dental Spray | Kalvatin Dermal Gel | Kalvatin Dental Gel | Kalvatin Dental Spray | Kalvatin Dental Gel | |
| Baxamed Ag | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SWITZERLAND | Haupt Strasse 4 , Binningen, Basle-Country SWITZERLAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 4/7/1997 | All prescription drugs 4/7/1997 | All prescription drugs 4/7/1997 | All prescription drugs 4/7/1997 | All prescription drugs 4/7/1997 | All prescription drugs 4/7/1997 | All prescription drugs 4/7/1997 | All prescription drugs 4/7/1997 | |
| Farmamondo | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SWITZERLAND | Viale Alessandro Volta 2 , Chiasso, Ticino SWITZERLAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 | All prescription drugs; 11/25/2001 |
| In Home Health Services | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SWITZERLAND | Case Postale 3112 , Delemont 1, Jura SWITZERLAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | All prescription drugs; 1/27/1992 | |
| The Alzheimers Buyers Club | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | SWITZERLAND | Post Fach , Rifferswil, SWITZERLAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | All prescription drugs 5/17/1995 | |
| Peschke Meditrade | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SWITZERLAND | Chasigass 6a , Hunenberg, Zug SWITZERLAND | 07/10/2025 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 Z - - 99 Animal Medical Devices, NEC | 86 M - - OE Collagen Corneal Shield | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | |
| Peschke Meritrade Gmbh | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SWITZERLAND | Boesch 6331 , Huenenberg, Zg SWITZERLAND | 07/10/2025 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 Z - - 99 Animal Medical Devices, NEC | 86 M - - OE Collagen Corneal Shield | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | |
| PESCHKE TRADE GMBH | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | SWITZERLAND | Boes Ch 67 , Hunenberg, Zoug SWITZERLAND | 07/10/2025 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 68 Z - - 99 Animal Medical Devices, NEC | 86 M - - OE Collagen Corneal Shield | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | |
| Chameleon Chao Ling Chemical Industrly Co | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TAIWAN | 21 Pu Ting Road , Hsinchu, TAIWAN | 09/18/2009 | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | Cosmetics Plus Cosmetic Kits containing eye make-up | 601(a) ; Pseudomona;aeruginosa; 6/4/1997 |
| Color Dreams | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TAIWAN | Lane 50 , No. 7 Nan Gong St.; Yong Kang Qu , Tai Nan Shi, Tainan Hsien TAIWAN | 09/18/2009 | 53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes) | Face Color Cosmetic; 7/14/06 | 601(a) | STAPHYLOCOCCUS : AUREUS; |
| Lucky Seeds International | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TAIWAN | NO. 1, 2 Fl , Alley 3 Lane 13; Kuh Luen Street , Taipei, TAIWAN | 05/13/2010 | 53 C - - -- Eye Makeup Prep | Eye Makeup Kits | 601(a) S. epidermidis |
| Maxigen Biotech, Inc. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TAIWAN | Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN | 09/18/2009 | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | Proto-Coll Anti-age Face Mask; 7/8/05 | 601(a) | ACINETOBACTER : CALCOACETICUS; PSEUDOMONAS : MALTOPHILIA; | 601(a) | PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS; | 601(a) | PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS; |
| Modish Collection International Co Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TAIWAN | No. 18 Lane 311 Cheng Chiang St , Tainan County, TAIWAN | 09/18/2009 | 53 C - - 06 Mascara (Eye Makeup Preparations) | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | Mascara; 3/10/05 | Mascara | 601(a); spore forming gram pos rods; yeast | PSEUDOMONAS : NOT SPECIATED; STAPHYLOCOCCUS : AUREUS; | 601 (a) Pseudomonas spp. S. aureus, Spore forming gram positive rods and yeast; 3/10/2005 |
| Prince Chemical Ind Co Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TAIWAN | No 12 Hsin Jen Road , Tainan, TAIWAN | 09/18/2009 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 G - - 05 Lipstick (Makeup Preparations, not for Eyes) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 3/31/95 | 3/31/95 | Cosmetic Tote bags containing lipstick and/or eyeshadow; 5/16/95 | 601(a) | CITROBACTER : FREUNDII; | 601(c) | STAPHYLOCOCCUS : SAPROPHYTICUS; | 601(a); 601(c) | STAPHYLOCOCCUS : SAPROPHYTICUS; CITROBACTER : FREUNDII; |
| Ying Piao (Eagle) Industrial Co., Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TAIWAN | 13 Zhong-Xin Rd , Pu Li Zhen , Nan Tou Xian, Nantou TAIWAN | 01/08/2016 | 53 C - - 02 Eyeliner (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | Nikka Notto Express Liquid Waterproof Eyeliner | Nikka Notto Express Liquid Waterproof Eyeliner | BURKHOLDERIA : CEPACIA; |
| SUN TEN PHARMACEUTICAL CO., LTD. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TAIWAN | 3 F , Beixin Rd., Sec. 3; No. 207 Xindian Dist. , New Taipei City Taipei - Special Municip, New Taipei City Taipei - Speci TAIWAN | 02/17/2016 | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | Red Yeast Rice | Product contains lovastatin per FDA analysis. |
| S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | THAILAND | 789/159 Moo 1, Nong Kho-Laemchabang Road , Si Racha, Chonburi THAILAND | 04/05/2012 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Body Shop Eye Colour 32 Chocolate | 601(a) Pseudomonas stutzeri, Acinetobacter Iwoffi, Micrococcus luteus and Moraxella nonliquifaciens |
| Siam Quality Industries Co Ltd | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | THAILAND | Sainoi , 49 Moo 1, Bangbuatong-Ladbualuang Road , Sai Noi, Nonthaburi THAILAND | 09/18/2009 | 53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Crayon Face Paints; 5/16/06 | Crayon Face Paint; 5/16/06 | Crayon Face Paints; 5/16/06 | Crayon Face Paints; 5/16/06 | 601(a); gram pos spore forming rods; yeast; mold | STAPHYLOCOCCUS : AUREUS; | 601(a); gram pos spore forming rods; yeast; mold | STAPHYLOCOCCUS : AUREUS; | 601(a); gram pos spore forming rods; yeast; mold | STAPHYLOCOCCUS : AUREUS; | 601(a); gram pos spore forming rods; yeast; mold | STAPHYLOCOCCUS : AUREUS; |
| H.C. Herb Club Laboratory | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | THAILAND | 91/1 Bangparok , Muang , Pathumthani, THAILAND | 08/02/2018 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | PAYA Dietary Supplement Product | PAYA Dietary Supplement Product | Problem(s); Sibutramine | Problem(s); Sibutramine |
| Inter Medical Lab AKA Inter Medical Clinic | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | 24-16 Phahonyothin Rd , Lardyao, Jatujak , Bangkok, THAILAND | 09/10/2009 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | Medislim-brand herbal diet pills | 1/27/2003 |
| International Merchandise Procurement | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | P O Box 336 (Mailing address) , Muang Phuket, Phuket THAILAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 |
| MEDICA PHARMA [INC. or CORP.] | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | UNKNOWN , KLONG-CHANG, BANGKOK, THAILAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 2/12/2003 | All Prescription Drugs;2/12/2003 | All Prescription Drugs;2/12/2003 | All Prescription Drugs;2/12/2003 | All Prescription Drugs;2/12/2003 | All Prescription Drugs;2/12/2003 | All Prescription Drugs;2/12/2003 | All Prescription Drugs;2/12/2003 |
| MedicaPharma Corp. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | 2591 Ladprao101 , Khlong Chan, Bangkapi , Bangkok, THAILAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 2/12/2003 | All prescription drugs;2/12/2003 | All prescription drugs;2/12/2003 | All prescription drugs;2/12/2003 | All prescription drugs;2/12/2003 | All prescription drugs;2/12/2003 | All prescription drugs;2/12/2003 | All prescription drugs;2/12/2003 |
| OLAN-KEMED CO., LTD | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | 176 , 16 Lat Phrao Rd , Chatuchak, Bangkok THAILAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | :"Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products ;2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | |
| Pa Yang | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | PO Box 8 , Sao Hai, Saraburi THAILAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | :"Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products ;2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 | |
| Sirirat Maihom (HealthCarePharma) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | 188 , 122 Saladang Road , Muang Chumphon, Chumphon THAILAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 | All prescription drugs 3/5/2002 |
| Vut, Suthapintu | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | THAILAND | P.O. Box 25 , Khlongkum , Bangkok, THAILAND | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 8/3/2001 | All Prescription Drugs; 8/3/2001 | All Prescription Drugs; 8/3/2001 | All Prescription Drugs; 8/3/2001 | All Prescription Drugs; 8/3/2001 | All Prescription Drugs; 8/3/2001 | All Prescription Drugs; 8/3/2001 | All Prescription Drugs; 8/3/2001 |
| Kardesler Ucan Yaglar Sanayi Anonim Sirketi | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TURKEY | No:1 Inonu Mahallesi Gebze , Plastikciler Osb. Mahallesi 42 , Gebze, Kocaeli TURKEY | 10/11/2022 | 53 A - - 04 Baby Wipes | Baby Wipes | Gram Positive Rods 601(a) Contaminated with microorganisms |
| Sapro Temizlik Urunleri Sanayi Ve Ticaret A.s | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | TURKEY | No:27 Ortakoy Merkez Mahallesi Ilter Bulvari , Silivri, Istanbul TURKEY | 06/22/2026 | 53 A - - 04 Baby Wipes | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | Up & Up Fragrance-Free Baby Wipes | Up & Up Fragrance-Free Baby Wipes | Up & Up Fragrance-Free Baby Wipes | Up & Up Fragrance-Free Baby Wipes | Up & Up Fragrance-Free Baby Wipes | 601(a) Burkholderia cepacia; Burkholderia gladioli | 601(a) Burkholderia cepacia; Burkholderia gladioli | 601(a) Burkholderia cepacia; Burkholderia gladioli | 601(a) Burkholderia cepacia; Burkholderia gladioli | 601(a) Burkholderia cepacia; Burkholderia gladioli |
| ACDC KOZMETIK SANAYI VE TICARET A.S. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Hal Mah Turgut Ozal Bulvan , Yeni Hal Kompleksi No:24 U Blok 6 , Akdeniz, TR-45 TURKEY | 03/26/2019 | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Sensual Honey- Herbal Mixed Paste | Sensual Honey- Herbal Mixed Paste | Sensual Honey- Herbal Mixed Paste | Sensual Honey- Herbal Mixed Paste | Sensual Honey- Herbal Mixed Paste | Sensual Honey- Herbal Mixed Paste | Sensual Honey- Herbal Mixed Paste | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil |
| AGROSOL GIDA | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Meric Mahallesi , 5746/4. Sokak No 32 , Bornova, Izmir TURKEY | 11/05/2024 | 31 K - - 99 Tea, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) | HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) | HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) | HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) | HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. |
| Cankatan Food Industry and Trade limited Company | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Evrenkoy Cad. Karanfil Sokak , No: 72/2/A , Ankara, TURKEY | 04/14/2023 | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | Product contains Sildenafil per FDA analysis | Product contains Sildenafil per FDA analysis |
| CANKATAN GIDA SANAYI VE TICARETLIM | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | 72/2/A Buyukkayacik Osb , Isletim Kayat, TURKEY | 04/14/2023 | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | Product contains Sildenafil per FDA analysis | Product contains Sildenafil per FDA analysis |
| GOKCE BITKISEL URUNLER-UFUK GOKCE | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Cevizli Mah. , Bayraktar Sokak A Blok No:5-7 17 , Kartal, Istanbul TURKEY | 01/16/2019 | 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Secret Miracle Honey | Leopard Miracle Honey | Secret Miracle Honey | Leopard Miracle Honey | Secret Miracle Honey | Leopard Miracle Honey | Leopard Miracle Honey | Leopard Miracle Honey | Leopard Miracle Honey | Secret Miracle Honey | Secret Miracle Honey | Leopard Miracle Honey | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. Claims noted on product website. | Secret Miracle Honey; FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. | FDA laboratory analysis confirmed product contains undeclared Sildenafil. Claims noted on product website. |
| HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Zonduldak Sok No 22a , Mah , Fevzi Cakmak, Kayseri TURKEY | 02/13/2019 | 02 - - - -- Whole Grains/Milled Grain Products/Starches | 03 - - - -- Bakery Products/Dough/Mixes/Icings | 04 - - - -- Macaroni/Noodle Products | 05 - - - -- Cereal Preparations/Breakfast Foods | 07 - - - -- Snack Food Items | 09 - - - -- Milk/Butter/Dried Milk Products | 12 - - - -- Cheese/Cheese Products | 13 - - - -- Ice Cream and related Products | 14 - - - -- Filled Milk/Imitation Milk Products | 15 - - - -- Eggs/Egg Products | 16 - - - -- Fishery/Seafood Products | 17 - - - -- Meats, Meat Products and Poultry | 18 - - - -- Vegetable Protein Products | 20 - - - -- Fruit/Fruit Products | 21 - - - -- Fruit/Fruit Products | 22 - - - -- Fruit/Fruit Products | 23 - - - -- Nuts/Edible Seeds | 24 - - - -- Vegetables/Vegetable Products | 25 - - - -- Vegetables/Vegetable Products | 26 - - - -- Vegetable Oils | 27 - - - -- Dressing/Condiments | 28 - - - -- Spices, Flavors And Salts | 29 - - - -- Drinks, Soft Drinks, and Waters | 30 - - - -- Beverage Bases/Concentrates/Nectars | 31 - - - -- Coffee/Tea | 32 - - - -- Alcoholic Beverages | 33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums | 34 - - - -- Chocolate/Cocoa Products/Cocoa beans | 35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings | 36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses | 37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties | 38 - - - -- Soups | 39 - - - -- Prepared Salad Products | 40 A - - -- Baked Goods (Baby) | 40 B - - -- Cereal (Baby) | 40 D - - -- Veg (Baby) | 40 E - - -- Fruit/Juice/Drink (Baby) | 40 F - - -- Meat Prod/Comb Meat Dinner (Baby) | 40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby) | 40 H - - -- High Meat Dinner/Cheese Food (Baby) | 40 I - - -- Fish-Seafood Prod (Baby) | 40 J - - -- Egg Prod (Baby) | 40 K - - -- Pudding/Custard (Baby) | 40 L - - -- Soups/Soup Mix (Baby) | 40 Q - - -- Pasta and Noodle Combination Dinners Without Meat | 40 X - - -- Market Basket Sampling | 40 Y - - -- Baby Food N.E.C. | 41 - - - -- Dietary Conv Food/Meal Replacements | 42 A - - -- Whole Edible Insects (adults and immature stages) | 42 B - - -- Milled Edible Insect Products | 42 C - - -- Edible Insect Bars | 42 D - - -- Edible Insect Bakery Products | 42 E - - -- Edible Insect Candy With Chocolate | 42 F - - -- Edible Insect Candy Without Chocolate | 42 G - - -- Edible Insect Capsules | 42 H - - -- Edible Insect Granola or Trail Mix | 42 I - - -- Edible Insect Jerky | 42 J - - -- Edible Insect Ice Cream and Related Products | 42 K - - -- Edible Insect Oils | 42 L - - -- Edible Insect Smoothies | 42 M - - -- Edible Insect Soups | 42 N - - -- Edible Insect Spreads And Pastes | 42 O - - -- Edible Insect Beverages | 42 P - - -- Edible Insect Protein: Simulated Meats and Tofu | 42 Q - - -- Edible Insect Salts and Spices | 42 R - - -- Edible Insect Products N.E.C. | 52 B - - 06 Corn Husks (Food Related) | 52 B - - 07 Snail Shells (Food Related) | 52 B - - 08 Sausage Casings, Artificial (Food Related) | 52 B - - 12 Non-Edible Bird's Nest | 52 D - - -- Live Animals | 54 - - - -- Vitamins/Minerals (Human/Animal); 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Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. | |
| HERBALART GIDA SAN VE TIC LTD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Karabas Mah. , Asim Efendi Sok. , Izmit, Kocaeli TURKEY | 12/11/2020 | 33 K - - 14 Taffy (Toffee), Kisses Candy, Soft, with Nuts and Fruit (without Chocolate) | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Stamina By Honey- Honey Mixed Herbal Paste (aka Epimedium Mixed Herbal Paste) | Stamina By Honey- Honey Mixed Herbal Paste (aka Epimedium Mixed Herbal Paste) | Stamina By Honey- Honey Mixed Herbal Paste (aka Epimedium Mixed Herbal Paste) | Stamina By Honey- Honey Mixed Herbal Paste (aka Epimedium Mixed Herbal Paste) | Stamina By Honey- Honey Mixed Herbal Paste (aka Epimedium Mixed Herbal Paste) | Stamina By Honey- Honey Mixed Herbal Paste (aka Epimedium Mixed Herbal Paste) | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil |
| MUBAREK DOGAL URUNLER GIDA SAN VE TIC LTD STI | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Ostim Mah , 1142 Sokak No 15/A , Yenimahalle, Ankara TURKEY | 12/28/2018 | 36 C - - -- Honey | 54 F - - -- Herbal & Botanicals(other than teas) | Leopard Miracle of Honey | Leopard Miracle of Honey | Undeclared sildenafil and tadalafil | Undeclared sildenafil and tadalafil |
| Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Asagi Dudullu Mahallesi , Hamz Yerlikaya Bulvari No 25/A , Umraniye, Istanbul TURKEY | 12/27/2018 | 36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | All Honey Dietary Supplements | All Honey Dietary Supplements | All Honey Dietary Supplements | All Honey Dietary Supplements | Due to import sample history, all honey DS products from this manufacturer appear to contain APIs. | Due to import sample history, all honey DS products from this manufacturer appear to contain APIs. | Due to import sample history, all honey DS products from this manufacturer appear to contain APIs. | Due to import sample history, all honey DS products from this manufacturer appear to contain APIs. |
| Sekerciler Tic. ve San. Ltd. Sti. | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | 2.Organize Sanayi Bolgesi , 2.Cadde No:11 , Yesilyurt, Malatya TURKEY | 09/28/2022 | 33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate) | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 F - - 12 Ginseng (Herbal & Botanicals, not Teas) | 54 F - - 75 Cocculus | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 L - - 01 Acetaminophen (Analgesic) | 60 L - - 01 Acetaminophen (Analgesic) | 60 L - - 01 Acetaminophen (Analgesic) | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 S - - 51 Tadalafil | 66 S - - 51 Tadalafil | 66 S - - 51 Tadalafil | 66 S - - 51 Tadalafil | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Honeymoon Herbal Honey | Honeymoon Herbal Honey | Honeymoon Herbal Honey | Honeymoon Herbal Honey | Honeymoon Herbal Honey | Honeymoon Herbal Honey | Black Horse Miracle Honey for Men | Versace Real Honey for Men | Honeymoon Herbal Honey | Black Panther Miracle Honey for Men | Secret Miracle Honey Extra Strength | Honeymoon Herbal Honey | Secret Miracle Honey Extra Strength | Versace Real Honey for Men | Black Panther Miracle Honey for Men | Black Horse Miracle Honey for Men | Honeymoon Herbal Honey | Secret Miracle Honey Extra Strength | Black Panther Miracle Honey for Men | Versace Real Honey for Men | Black Panther Miracle Honey for Men | Black Horse Miracle Honey for Men | Secret Miracle Honey Extra Strength | Versace Real Honey for Men | Honeymoon Herbal Honey | Honeymoon Herbal Honey | Black Panther Miracle Honey for Men | Versace Real Honey for Men | Secret Miracle Honey Extra Strength | Black Horse Miracle Honey for Men | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Acetaminophen, Sildenafil, and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Acetaminophen, Sildenafil, and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Acetaminophen, Sildenafil, and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Acetaminophen, Sildenafil, and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis found undeclared Sildenafil and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Acetaminophen, Sildenafil, and Tadalafil | FDA laboratory analysis confirmed product contains undeclared Sildenafil, Tadalafil, and Acetaminophen | FDA laboratory analysis confirmed product contains undeclared Sildenafil and Tadalafil |
| Veysi Topuz | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | TURKEY | Z Blok No 30-31 Hal Mah. Yeni Hal Kompleksi , Akdeniz, ICEL TURKEY | 08/06/2021 | 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | EPIMEDIUM AND GINSENG HERBAL SUPPLEMENTS | THEMRA EPIMEDIUM TURKISH HORNY GOAT WEED | Problem: SILDENAFIL | Problem: SILDENAFIL |
| Farmakom Ltd | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | UKRAINE | 17 Yuriivska Street , Kharkiv, Kharkivska UKRAINE | 08/11/2020 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Male Potency-F | Male Potency-F; FDA laboratory analysis confirmed product contains Sildenafil. | FDA laboratory analysis confirmed product contains Sildenafil. |
| Aog Offshore | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED ARAB EMIRATES | P O Box 111717 , Dubai, UNITED ARAB EMIRATES | 09/10/2009 | 66 S - - 51 Tadalafil | Tadalafil tablets | Shipper associated with Unicure Remedies Pvt.; Ltd.; India; often declated as the manufacturer. |
| MEIYUME (UK) Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | UNITED KINGDOM | Aintree Avenue , Trowbridge, Wiltshire UNITED KINGDOM | 04/09/2010 | 53 C - - 06 Mascara (Eye Makeup Preparations) | The Body Shop Define and Lengthen Mascara | 601(a); B. licheniformis, B. cereus |
| Neal's Yard Remedies (International) Ltd. | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | UNITED KINGDOM | Peacemarsh , Gillingham, Dorset UNITED KINGDOM | 10/02/2013 | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | Eye Shadow (Cocoa) | 601(a) B. species and B. liceniformis | ENTEROCOCCUS : CASSELIFLAVUS; BURKHOLDERIA : CEPACIA; |
| Aceso Universal LTD | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | Flat 241 , The Blenheim Centre; Prince Regent Road , Hounslow, UNITED KINGDOM | 06/08/2017 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Alan Pharmaceuticals | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | 204 Essex Road , London, UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 | All prescription drugs 5/24/1996 |
| Amimed Direct Ltd | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | P.O. Box 6983 , London, England UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | All prescription drugs 6/30/1995 | |
| Aposave Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | 107-111 Fleet Street , London, UNITED KINGDOM | 12/13/2016 | 61 P - - 99 Anti-Diabetic N.E.C. | Diabetic Pen | |
| BURWASH PHARMACY | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | 9 Burwash Road , Hove, East Sussex UNITED KINGDOM | 09/29/2021 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | |
| CEDARWOOD PHARMACY | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | 5 Peterwood Way , Croydon, CRY UNITED KINGDOM | 01/25/2018 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | All Prescription Drug Products | |
| Concept Shopping Ltd. (aka ukyes.com) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | unknown , Staffordshire, UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 ; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| InterLab | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | BCM Box 5890 , London, England UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | All preseciption drugs; 1/27/1992 | |
| International Antiaging Systems (IAS) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | P O Box 2995 , Muswell Hill, London UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | All prescription drugs 5/4/1993 | |
| Masters Marketing Company | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | Masters House , 5 Sandridge Close , Harrow, Middlesex UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drugs | 11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 |
| Medicines International | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | P.O. Box 5217 , East Kilbride, Glasgow UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . | All prescription drugs 11/22/1996 This firm has been identified as providing unapporved drugs to individuals in the US through . |
| Menscare Services | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | 1 Woodgate House , Woodlane, Uttoexeter , Staffordshire, England UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Pharmhub Pharmacy | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | 149D Pleck Road , Walsall, West Midlands UNITED KINGDOM | 03/23/2026 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; |
| Quality Health Inc. | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED KINGDOM | 401 Langham House , 29-30 Margaret Street , London, UNITED KINGDOM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 12/19/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 | All prescription drugs 8/4/1997 |
| A. Nelson & Co., Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED KINGDOM | 5 Endeavour Way , London, UNITED KINGDOM | 04/21/2025 | 65 Q - - 99 Relaxant N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | RESCUE PET REMEDY | RESCUE PET REMEDY | |
| Aromesse Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED KINGDOM | Croft Farm , Gainsborough, Lincolnshire UNITED KINGDOM | 07/23/2020 | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 G - - 05 Lipstick (Makeup Preparations, not for Eyes) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 68 Z - - 99 Animal Medical Devices, NEC | 68 Z - - 99 Animal Medical Devices, NEC | DERMACTON SHAMPOO BAR | ULTRASALVE BALM | ULTRASALVE BALM | ULTRASALVE BALM | DERMACTON SHAMPOO BAR | ULTRASALVE BALM | |
| Boehringer Ingleheim Limited | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED KINGDOM | Ellesfield Avenue , Bracknell, Berkshire UNITED KINGDOM | 08/31/2023 | 62 J - - 14 Pergolide Mesylate (Anti-Parkinsonian) | PRASCEND (pergolide as pergolide mesylate) | |
| HILTON HERBS LTD | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED KINGDOM | Downclose Farm , Downclose Lane , Crewkerne, Somerset UNITED KINGDOM | 10/22/2021 | 54 E - - 84 Milk Thistle | 54 E - - 84 Milk Thistle | 54 F - - 84 Milk Thistle (Herbal & Botanical other than teas) | 54 F - - 84 Milk Thistle (Herbal & Botanical other than teas) | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 M - - 99 Mixed Feed Ration For Animals, N.E.C. | 70 Y - - 99 Animal Feeds, N.E.C. | 70 Y - - 99 Animal Feeds, N.E.C. | 70 Y - - 99 Animal Feeds, N.E.C. | 70 Y - - 99 Animal Feeds, N.E.C. | Milk Thistle Plus Gold | Milk Thistle Plus | Pigeon Re-Coop Plus | Pigeon Super Fit | Bye Bye Itch Lotion; 250ml | Bye Bye Itch Lotion; 500ml | Bye Bye Itch Lotion | Bye Bye Itch Lotion; 250ml | Mud Defender Lotion; 250 ml | Bye Bye Itch Lotion; 500ml | Mud Defender Lotion; 500 ml | Bye Bye Itch Lotion; 250ml | Milk Thistle Plus | Mud Defender Lotion; 250 ml | Mud Defender Lotion; 500 ml | Digest Support | Calm & Collected | Detox Support | Milk Thistle Plus Gold | Bye Bye Itch Lotion; 500ml | Pigeon Re-Coop Plus | Mobility Support | Pigeon Super Fit | Milk Thistle Plus | Milk Thistle Plus Gold | Calm & Collected | Digest Support | |
| Kusuri Products Limited | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED KINGDOM | Unit 12, Wentworth Road , Heathfield Industrial Estate , Newton Abbot, Devon UNITED KINGDOM | 12/17/2019 | 55 Q - - 41 Benzalkonium Chloride (Pharmaceutic Necessity - Preservative) | 62 F - - 20 Iodine (Anti-Infective, Topical) | 62 F - - 99 Anti-Infective, Topical N.E.C. | 62 L - - 02 Flubendazole (Anti-Protozoal, Anti-Leishmanial, Anti-Malarial) | 64 D - - 99 Emollient, Lubricant, N.E.C. | BENZYLKONIUM CHLORIDE SOLUTION | IODALINE SOLUTION | 2-PHENOXYETHANOL | FLUBENDAZOLE | ORAHESIVE POWDER | |
| Optimised Energetics Limited | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED KINGDOM | Unit 4 , Castle Keep business centre ; High Street , Wadhurst, East Sussex UNITED KINGDOM | 03/07/2016 | 56 G - - 99 Antifungal N.E.C. | 61 H - - 99 Anti-Bacterial, N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | Colloidal Silver Topical Animal Drug Products | Colloidal Silver Topical Animal Drug Products | Colloidal Silver Topical Animal Drug Products | |
| Superfix Supplements Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED KINGDOM | Rallt Deg The Gatewaywirral , Caernarfoncaernarfon, UNITED KINGDOM | 06/02/2017 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 70 Y - - 99 Animal Feeds, N.E.C. | Superfix Performance - Equine Nutriceutical | Superfix Performance - Equine Nutriceutical | Superfix Performance - Equine Nutriceutical | |
| GRYPHON LLC | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED STATES | 16810 Kenton Dr Ste 240 , Huntersville, NC 28078-4845 UNITED STATES | 03/23/2026 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; | All Drug and Drug Products; |
| PRICEMDS.COM INC | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED STATES | 720 Brooker Creek Blvd Ste 221 , Oldsmar, FL 34677-2937 UNITED STATES | 04/19/2021 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | All Prescription Drug Products; All prescription drug products from any foreign manufacturer, imported by this firm, are subject to detention without physical examination. | |
| Samson Medical Technologies, LLC | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | UNITED STATES | 1815 Garden Ave , Cherry Hill, NJ 08003-2303 UNITED STATES | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs (finished dosage form) | 10/16/2006 ;Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as �sterile bulk� and �For pharmacy compounding only�, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 |
| Dr. Xie's Jing-Tang Herbal, Inc. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED STATES | 4815 Nw 8th St , Ocala, FL 34482-8773 UNITED STATES | 08/10/2016 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 - - - -- Human and Animal Drugs | All Products | All Products | |
| Noahs Arc Inc | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED STATES | 9552 Seibt Rd , Bradford, OH 45308-9603 UNITED STATES | 11/29/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Four Yellows | White Tiger | Bleeder USA | Desert Fire | Pro-K | Sinking | VI Formula | Hot Feet USA | Tendon | Nerve Restore | Lady Plus Formula | Four Yellows | Desert Fire | Nerve Restore | Lady Plus Formula | Hot Feet USA | VI Formula | White Tiger | Tendon | Pro-K | Sinking | Bleeder USA | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 | FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669 |
| Pet Pawsitive | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | UNITED STATES | 172 Trade St , Lexington, KY 40511-2607 UNITED STATES | 01/13/2020 | 54 Y - - 15 Hemp Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | Hemp oil for dogs | |
| HAVYCO | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | VIETNAM | No. 45, Group 1, National Highway 14 , Son Hiep Hamlet, Tho Son Commune , Bu Dang District, Binh Phuoc VIETNAM | 09/14/2021 | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Vy & Tea | Vy & Tea | Vy & Tea | FDA laboratory analysis confirmed product contains undeclared Sibutramine | FDA laboratory analysis confirmed product contains undeclared Sibutramine | FDA laboratory analysis confirmed product contains undeclared Sibutramine |
| MAT XI S.G CO., LTD | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | VIETNAM | 9 , 148, Tan Tienbeien Hoa , Bien Goa, VIETNAM | 05/14/2019 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) | 63 H - - 17 Phenolphthalein (Cathartic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Go lean Detox Capsules | Go lean Detox Capsules | Go lean Detox Capsules | Go lean Detox Capsules; FDA laboratory analysis confirmed product contains undeclared sibutramine and phenolphthalein | FDA laboratory analysis confirmed product contains undeclared sibutramine and phenolphthalein. | FDA laboratory analysis confirmed product contains undeclared sibutramine and phenolphthalein. | FDA laboratory analysis confirmed product contains undeclared sibutramine and phenolphthalein |
Where this came from
Every record above links the page it was taken from and quotes the sentence that states it. These are the 6 sources this dataset was assembled from.
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_197.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1141.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1147.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_136.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1140.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1133.html
Machine-readable
- data.jsonThe whole dataset — every record with its source URL and source quote.
- Open Knowledge Format bundleOne JSON object per line — every record's frontmatter and quoted span exactly as it is held here, in one fetch.
- How this is made and checkedWhat "verified against source" does and does not mean.