**Firm:** Lvmh Fragranc Cosmetics

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** SINGAPORE

**Address:** 31 Jurong Port Rd , Jurong Logistics Hub, SINGAPORE

**Date published:** 04/11/2012

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations)

**Product:** Mascara (Fresh Supernova)

**FDA notes:** 601(a) Enterococcus casseliflavus; Microccus luteus and Staphylococcus lentus

> Lvmh Fragranc Cosmetics Date Published : 04/11/2012 31 Jurong Port Rd , Jurong Logistics Hub, SINGAPORE 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 04/26/2021 Desc: Mascara (Fresh Supernova) Notes: 601(a) Enterococcus casseliflavus; Microccus luteus and Staphylococcus lentus

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Lvmh Fragranc Cosmetics — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** #1 Drugstore Online (John Wong)

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SINGAPORE

**Address:** P.O. Box 115 , Singapore, SINGAPORE

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** 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

> #1 Drugstore Online (John Wong) Date Published : 09/10/2009 P.O. Box 115 , Singapore, SINGAPORE 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 02/11/2021 Notes: All prescription drugs; 7/31/2001 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 7/31/2001 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 7/31/2001 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 7/31/2001 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 7/31/2001 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 7/31/2001 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 7/31/2001 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 7/31/2001

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

#1 Drugstore Online (John Wong) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Netzah Pharmacy Co

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SINGAPORE

**Address:** 115 Airport Cargo Road , #02-20 Cargo Agents Building C , Singapore, SINGAPORE

**Date published:** 04/18/2016

**Product code:** 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic) | 60 T - - 15 Naltrexone (Antagonist)

**Product:** Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules | Naltrexone 4.5mg Capsules

> Netzah Pharmacy Co Date Published : 04/18/2016 115 Airport Cargo Road , #02-20 Cargo Agents Building C , Singapore, SINGAPORE 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules Notes: 60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic) Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules Notes: 60 T - - 15 Naltrexone (Antagonist) Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules Notes:

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Netzah Pharmacy Co — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Bee Natural

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** SOUTH AFRICA

**Address:** Plot 191 Canyon , Randvaal, Gauteng SOUTH AFRICA

**Date published:** 09/14/2016

**Product code:** 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C.

**Product:** Living Clay Face Mask | Living Clay Face Mask

**FDA notes:** 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;

> Bee Natural Date Published : 09/14/2016 Plot 191 Canyon , Randvaal, Gauteng SOUTH AFRICA 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 09/14/2016 Desc: Living Clay Face Mask Notes: CANDIDA PARAPSILOSIS; KLUYVERA INTERMEDIA; AEROMONAS SPP. Problems: ENTEROBACTER : ASBURIAE; ENTEROBACTER : CLOACAE; ESCHERICHIA : COLI (TYPICAL); KLEBSIELLA : OXYTOCA; KLEBSIELLA : PNEUMONIAE SUBSP. PNEUMONIAE; KLUYVERA : CRYOCRESCENS; PSEUDOMONAS : PUTIDA; 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/14/2016 Desc: Living Clay Face Mask Notes: CANDIDA PARAPSILOSIS; KLUYVERA INTERMEDIA; AEROMONAS SPP. Problems: ENTEROBACTER : ASBURIAE; ENTEROBACTER : CLOACAE; ESCHERICHIA : COLI (TYPICAL); KLEBSIELLA : OXYTOCA; KLEBSIELLA : PNEUMONIAE SUBSP. PNEUMONIAE; KLUYVERA : CRYOCRESCENS; PSEUDOMONAS : PUTIDA;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Bee Natural — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Alants (aka Jansen van Vuuren)

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SOUTH AFRICA

**Address:** 8A Howe Circle , Homestead , Germiston, Gauteng SOUTH AFRICA

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All Prescription Drugs

**FDA notes:** 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

> Alants (aka Jansen van Vuuren) Date Published : 09/10/2009 8A Howe Circle , Homestead , Germiston, Gauteng SOUTH AFRICA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 02/11/2021 Desc: All Prescription Drugs Notes: 3/22/2000 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs ; 3/22/2000 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs ; 3/22/2000 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs ; 3/22/2000 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs ; 3/22/2000 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs ; 3/22/2000 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs ; 3/22/2000 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs ; 3/22/2000

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Alants (aka Jansen van Vuuren) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Jansen van Vuuren (aka alants)

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SOUTH AFRICA

**Address:** 8A Howe Circle , Homestead , Germiston, Gauteng SOUTH AFRICA

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All Prescription Drugs

**FDA notes:** 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) Date Published : 09/10/2009 8A Howe Circle , Homestead , Germiston, Gauteng SOUTH AFRICA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All Prescription Drugs Notes: 3/22/2000 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 3/22/2000 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 3/22/2000 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 3/22/2000 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 3/22/2000 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 3/22/2000 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 3/22/2000 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 3/22/2000

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Jansen van Vuuren (aka alants) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** The Somatropin Drugstore

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SOUTH AFRICA

**Address:** 36 Adderly Street , Cape Town, SOUTH AFRICA

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** 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

> The Somatropin Drugstore Date Published : 09/10/2009 36 Adderly Street , Cape Town, SOUTH AFRICA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 60 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 61 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 62 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 63 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 64 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 65 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01 66 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 3/27/01

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

The Somatropin Drugstore — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Afriplex (Pty) Ltd.

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SOUTH AFRICA

**Address:** 10 De Vreugde Crescent , Paarl, Western Cape SOUTH AFRICA

**Date published:** 10/19/2016

**Product code:** 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.

**Product:** 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

> Afriplex (Pty) Ltd. Date Published : 10/19/2016 10 De Vreugde Crescent , Paarl, Western Cape SOUTH AFRICA 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Skin Care Remedy 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Joint Health Remedy 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Skin Care Combo 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Glossy Coat Remedy 61 X - - 99 Anti-Histaminic N.E.C. Date Published: 10/19/2016 Desc: Regal Skin Care Combo 61 X - - 99 Anti-Histaminic N.E.C. Date Published: 10/19/2016 Desc: Regal Skin Care Remedy 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/19/2016 Desc: Regal Joint Health Remedy 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/19/2016 Desc: Regal Glossy Coat Remedy

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

Afriplex (Pty) Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** HERBEX PTY LIMITED

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SOUTH AFRICA

**Address:** Unit 2 , Nexus Place , Cape Town, Western Cape SOUTH AFRICA

**Date published:** 10/19/2016

**Product code:** 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.

**Product:** 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

> HERBEX PTY LIMITED Date Published : 10/19/2016 Unit 2 , Nexus Place , Cape Town, Western Cape SOUTH AFRICA 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Glossy Coat Remedy 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Skin Care Combo 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Joint Health Remedy 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/19/2016 Desc: Regal Skin Care Remedy 61 X - - 99 Anti-Histaminic N.E.C. Date Published: 10/19/2016 Desc: Regal Skin Care Combo 61 X - - 99 Anti-Histaminic N.E.C. Date Published: 10/19/2016 Desc: Regal Skin Care Remedy 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/19/2016 Desc: Regal Joint Health Remedy 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/19/2016 Desc: Regal Glossy Coat Remedy

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

HERBEX PTY LIMITED — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** OPHTHALMICA PTY LTD

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SOUTH AFRICA

**Address:** Park Bldg , 101 Albert Road , Centurion, Gauteng SOUTH AFRICA

**Date published:** 07/10/2025

**Product code:** 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

**Product:** Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution

> OPHTHALMICA PTY LTD Date Published : 07/10/2025 Park Bldg , 101 Albert Road , Centurion, Gauteng SOUTH AFRICA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 68 Z - - 99 Animal Medical Devices, NEC Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 86 M - - OE Collagen Corneal Shield Date Published: 07/10/2025 Desc: Riboflavin Solution Notes:

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

OPHTHALMICA PTY LTD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Southern Implants, (Pty.) Ltd.

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SOUTH AFRICA

**Address:** One Albert Road , Irene, Gauteng, SOUTH AFRICA

**Date published:** 07/10/2025

**Product code:** 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

**Product:** Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution

> Southern Implants, (Pty.) Ltd. Date Published : 07/10/2025 One Albert Road , Irene, Gauteng, SOUTH AFRICA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 68 Z - - 99 Animal Medical Devices, NEC Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 86 M - - OE Collagen Corneal Shield Date Published: 07/10/2025 Desc: Riboflavin Solution Notes:

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

Southern Implants, (Pty.) Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** SOUTHERN MEDICAL (PTY) LTD

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SOUTH AFRICA

**Address:** 55 Regency, Route 21 Corporate Park, Irene, Pretoria , Irene, Gauteng SOUTH AFRICA

**Date published:** 07/10/2025

**Product code:** 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

**Product:** Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution

> SOUTHERN MEDICAL (PTY) LTD Date Published : 07/10/2025 55 Regency, Route 21 Corporate Park, Irene, Pretoria , Irene, Gauteng SOUTH AFRICA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 65 N - - 67 Sodium Rose Bengal I 125 (Radioactive Agent) Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 68 Z - - 99 Animal Medical Devices, NEC Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 86 M - - OE Collagen Corneal Shield Date Published: 07/10/2025 Desc: Riboflavin Solution Notes:

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

SOUTHERN MEDICAL (PTY) LTD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** BEAUNIVATIONS SL

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** SPAIN

**Address:** Placa Vapor 11 12c , Badalona, Barcelona SPAIN

**Date published:** 04/20/2026

**Product code:** 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)

**Product:** 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

**FDA notes:** 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.

> BEAUNIVATIONS SL Date Published : 04/20/2026 Placa Vapor 11 12c , Badalona, Barcelona SPAIN 53 C - - 04 Eye Lotion (Eye Makeup Preparations) Date Published: 04/20/2026 Desc: Filling Anti-Wrinkle Lift Syringe Notes: 601(a) Gram-Positive cocci; Aerococcus viridans. 53 C - - 14 Eyelash and Eyebrow Treatments-Gel, Oil, Primer, Conditioners, Serum, Fortifiers (Eye Makeup Prepara Date Published: 04/20/2026 Desc: Filling Anti-Wrinkle Lift Syringe Notes: 601(a) Gram-Positive cocci; Aerococcus viridans. 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) Date Published: 04/20/2026 Desc: Filling Anti-Wrinkle Lift Syringe Notes: 601(a) Gram-Positive cocci; Aerococcus viridans. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/20/2026 Desc: Filling Anti-Wrinkle Lift Syringe Notes: 601(a) Gram-Positive cocci; Aerococcus viridans. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 04/20/2026 Desc: Filling Anti-Wrinkle Lift Syringe Notes: 601(a) Gram-Positive cocci; Aerococcus viridans.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

BEAUNIVATIONS SL — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Libertarian Solutions (c/o Mr. Dennis Faulkner)

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SPAIN

**Address:** Nogal No. 7 , Torreblanca Fuengirola , Malaga, SPAIN

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All prescription drugs

**FDA notes:** 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

> Libertarian Solutions (c/o Mr. Dennis Faulkner) Date Published : 09/10/2009 Nogal No. 7 , Torreblanca Fuengirola , Malaga, SPAIN 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All prescription drugs Notes: 3/27/01 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 3/27/2001 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 3/27/2001 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 3/27/2001 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 3/27/2001 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 3/27/2001 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 3/27/2001 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 3/27/2001

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Libertarian Solutions (c/o Mr. Dennis Faulkner) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Mail Pack Ship, S.L.

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SPAIN

**Address:** Av De Las Naciones Unidas 43 , Puerto Banus, SPAIN

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** 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

> Mail Pack Ship, S.L. Date Published : 09/10/2009 Av De Las Naciones Unidas 43 , Puerto Banus, SPAIN 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Drug Products;11/12/1999

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Mail Pack Ship, S.L. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** WineDirect.net (Jorge Galet)

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SPAIN

**Address:** Calle Gomez Becerra 18 11d , Caceres, Caceres SPAIN

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** 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

> WineDirect.net (Jorge Galet) Date Published : 09/10/2009 Calle Gomez Becerra 18 11d , Caceres, Caceres SPAIN 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 60 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 61 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 62 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 63 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 64 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 65 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002 66 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 2/19/2002

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

WineDirect.net (Jorge Galet) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Laboratorios Calier, S.A.

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SPAIN

**Address:** Parc Empresarial Mas Blau Ii C/ , Barcelona, SPAIN

**Date published:** 08/07/2019

**Product code:** 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

**FDA notes:** 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)

> Laboratorios Calier, S.A. Date Published : 08/07/2019 Parc Empresarial Mas Blau Ii C/ , Barcelona, SPAIN 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 56 - - - -- Antibiotics (Human/Animal) Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 61 - - - -- Human and Animal Drugs Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 62 - - - -- Human and Animal Drugs Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 63 - - - -- Human and Animal Drugs Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 64 - - - -- Human and Animal Drugs Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 65 - - - -- Human and Animal Drugs Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution) 66 - - - -- Human and Animal Drugs Date Published: 08/07/2019 Notes: Respigen 15 (Tocopheryl Acetate + Pangamic Acid + Selenium Solution)

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

Laboratorios Calier, S.A. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Enzymatica AB

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SWEDEN

**Address:** Forskningsbyn Ideon , Ideon Science Park , Lund, Skane Lan SWEDEN

**Date published:** 03/13/2015

**Product code:** 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

**Product:** 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

> Enzymatica AB Date Published : 03/13/2015 Forskningsbyn Ideon , Ideon Science Park , Lund, Skane Lan SWEDEN 61 W - - -- A-Fungal Date Published: 03/13/2015 Desc: Kalvatin Dermal Gel 62 F - - -- A-Infective, Topical Date Published: 03/13/2015 Desc: Kalvatin Dermal Gel 62 G - - -- A-Inflammatory Date Published: 03/13/2015 Desc: Kalvatin Dental Gel 62 G - - -- A-Inflammatory Date Published: 03/13/2015 Desc: Kalvatin Dental Spray 62 G - - -- A-Inflammatory Date Published: 03/13/2015 Desc: Kalvatin Dermal Gel 62 S - - -- A-Seborrheic Date Published: 03/13/2015 Desc: Kalvatin Dermal Gel 63 R - - -- Dental Caries Prophyl Date Published: 03/13/2015 Desc: Kalvatin Dental Spray 63 R - - -- Dental Caries Prophyl Date Published: 03/13/2015 Desc: Kalvatin Dental Gel 63 S - - -- Dental Protect Date Published: 03/13/2015 Desc: Kalvatin Dental Spray 63 S - - -- Dental Protect Date Published: 03/13/2015 Desc: Kalvatin Dental Gel 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/13/2015 Desc: Kalvatin Dental Spray 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/13/2015 Desc: Kalvatin Dermal Gel 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/13/2015 Desc: Kalvatin Dental Gel 68 R - - -- Dental-Nonhuman Date Published: 03/26/2024 Desc: Kalvatin Dental Spray 68 R - - -- Dental-Nonhuman Date Published: 03/26/2024 Desc: Kalvatin Dental Gel

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

Enzymatica AB — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Baxamed Ag

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SWITZERLAND

**Address:** Haupt Strasse 4 , Binningen, Basle-Country SWITZERLAND

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** 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

> Baxamed Ag Date Published : 09/10/2009 Haupt Strasse 4 , Binningen, Basle-Country SWITZERLAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 4/7/1997

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Baxamed Ag — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Farmamondo

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SWITZERLAND

**Address:** Viale Alessandro Volta 2 , Chiasso, Ticino SWITZERLAND

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All prescription drugs

**FDA notes:** 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

> Farmamondo Date Published : 09/10/2009 Viale Alessandro Volta 2 , Chiasso, Ticino SWITZERLAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All prescription drugs Notes: 11/25/2001 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 11/25/2001 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 11/25/2001 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 11/25/2001 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 11/25/2001 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 11/25/2001 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 11/25/2001 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 11/25/2001

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Farmamondo — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** In Home Health Services

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SWITZERLAND

**Address:** Case Postale 3112 , Delemont 1, Jura SWITZERLAND

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** 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

> In Home Health Services Date Published : 09/10/2009 Case Postale 3112 , Delemont 1, Jura SWITZERLAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 56 - - - -- Antibiotics (Human/Animal) Date Published: 09/10/2009 Notes: All prescription drugs; 1/27/1992 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 60 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 61 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 62 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 63 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 64 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 65 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992 66 - - - -- Human and Animal Drugs Date Published: 03/13/2023 Notes: All prescription drugs; 1/27/1992

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

In Home Health Services — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** The Alzheimers Buyers Club

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** SWITZERLAND

**Address:** Post Fach , Rifferswil, SWITZERLAND

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** 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

> The Alzheimers Buyers Club Date Published : 09/10/2009 Post Fach , Rifferswil, SWITZERLAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 56 - - - -- Antibiotics (Human/Animal) Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 5/17/1995

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

The Alzheimers Buyers Club — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Peschke Meditrade

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SWITZERLAND

**Address:** Chasigass 6a , Hunenberg, Zug SWITZERLAND

**Date published:** 07/10/2025

**Product code:** 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

**Product:** Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution

> Peschke Meditrade Date Published : 07/10/2025 Chasigass 6a , Hunenberg, Zug SWITZERLAND 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 68 Z - - 99 Animal Medical Devices, NEC Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 86 M - - OE Collagen Corneal Shield Date Published: 07/10/2025 Desc: Riboflavin Solution Notes:

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

Peschke Meditrade — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Peschke Meritrade Gmbh

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SWITZERLAND

**Address:** Boesch 6331 , Huenenberg, Zg SWITZERLAND

**Date published:** 07/10/2025

**Product code:** 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

**Product:** Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution

> Peschke Meritrade Gmbh Date Published : 07/10/2025 Boesch 6331 , Huenenberg, Zg SWITZERLAND 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 68 Z - - 99 Animal Medical Devices, NEC Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 86 M - - OE Collagen Corneal Shield Date Published: 07/10/2025 Desc: Riboflavin Solution Notes:

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

Peschke Meritrade Gmbh — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** PESCHKE TRADE GMBH

**Import alert:** 68-19

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"

**Country:** SWITZERLAND

**Address:** Boes Ch 67 , Hunenberg, Zoug SWITZERLAND

**Date published:** 07/10/2025

**Product code:** 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

**Product:** Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution | Riboflavin Solution

> PESCHKE TRADE GMBH Date Published : 07/10/2025 Boes Ch 67 , Hunenberg, Zoug SWITZERLAND 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 65 N - - 66 Sodium Phosphate P 32 (Radioactive Agent) Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 68 Z - - 99 Animal Medical Devices, NEC Date Published: 07/10/2025 Desc: Riboflavin Solution Notes: 86 M - - OE Collagen Corneal Shield Date Published: 07/10/2025 Desc: Riboflavin Solution Notes:

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1147.html>

PESCHKE TRADE GMBH — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Chameleon Chao Ling Chemical Industrly Co

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TAIWAN

**Address:** 21 Pu Ting Road , Hsinchu, TAIWAN

**Date published:** 09/18/2009

**Product code:** 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)

**Product:** Cosmetics Plus Cosmetic Kits containing eye make-up

**FDA notes:** 601(a) ; Pseudomona;aeruginosa; 6/4/1997

> Chameleon Chao Ling Chemical Industrly Co Date Published : 09/18/2009 21 Pu Ting Road , Hsinchu, TAIWAN 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) Date Published: 03/29/2021 Desc: Cosmetics Plus Cosmetic Kits containing eye make-up Notes: 601(a) ; Pseudomona;aeruginosa; 6/4/1997

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Chameleon Chao Ling Chemical Industrly Co — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Color Dreams

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TAIWAN

**Address:** Lane 50 , No. 7 Nan Gong St.; Yong Kang Qu , Tai Nan Shi, Tainan Hsien TAIWAN

**Date published:** 09/18/2009

**Product code:** 53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes)

**Product:** Face Color Cosmetic; 7/14/06

**FDA notes:** 601(a) | STAPHYLOCOCCUS : AUREUS;

> Color Dreams Date Published : 09/18/2009 Lane 50 , No. 7 Nan Gong St.; Yong Kang Qu , Tai Nan Shi, Tainan Hsien TAIWAN 53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes) Date Published: 09/18/2009 Desc: Face Color Cosmetic; 7/14/06 Notes: 601(a) Problems: STAPHYLOCOCCUS : AUREUS;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Color Dreams — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Lucky Seeds International

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TAIWAN

**Address:** NO. 1, 2 Fl , Alley 3 Lane 13; Kuh Luen Street , Taipei, TAIWAN

**Date published:** 05/13/2010

**Product code:** 53 C - - -- Eye Makeup Prep

**Product:** Eye Makeup Kits

**FDA notes:** 601(a) S. epidermidis

> Lucky Seeds International Date Published : 05/13/2010 NO. 1, 2 Fl , Alley 3 Lane 13; Kuh Luen Street , Taipei, TAIWAN 53 C - - -- Eye Makeup Prep Date Published: 05/13/2010 Desc: Eye Makeup Kits Notes: 601(a) S. epidermidis

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Lucky Seeds International — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Maxigen Biotech, Inc.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TAIWAN

**Address:** Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN

**Date published:** 09/18/2009

**Product code:** 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)

**Product:** Proto-Coll Anti-age Face Mask; 7/8/05

**FDA notes:** 601(a) | ACINETOBACTER : CALCOACETICUS; PSEUDOMONAS : MALTOPHILIA; | 601(a) | PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS; | 601(a) | PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS;

> Maxigen Biotech, Inc. Date Published : 09/18/2009 Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/18/2009 Notes: 601(a) Problems: ACINETOBACTER : CALCOACETICUS; PSEUDOMONAS : MALTOPHILIA; 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 09/18/2009 Desc: Proto-Coll Anti-age Face Mask; 7/8/05 Notes: 601(a) Problems: PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS; 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 09/18/2009 Notes: 601(a) Problems: PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Maxigen Biotech, Inc. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Modish Collection International Co Ltd.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TAIWAN

**Address:** No. 18 Lane 311 Cheng Chiang St , Tainan County, TAIWAN

**Date published:** 09/18/2009

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations) | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.

**Product:** Mascara; 3/10/05 | Mascara

**FDA notes:** 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

> Modish Collection International Co Ltd. Date Published : 09/18/2009 No. 18 Lane 311 Cheng Chiang St , Tainan County, TAIWAN 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: Mascara; 3/10/05 Notes: 601(a); spore forming gram pos rods; yeast Problems: PSEUDOMONAS : NOT SPECIATED; STAPHYLOCOCCUS : AUREUS; 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 03/29/2021 Desc: Mascara Notes: 601 (a) Pseudomonas spp. S. aureus, Spore forming gram positive rods and yeast; 3/10/2005

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Modish Collection International Co Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Prince Chemical Ind Co Ltd

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TAIWAN

**Address:** No 12 Hsin Jen Road , Tainan, TAIWAN

**Date published:** 09/18/2009

**Product code:** 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.

**Product:** 3/31/95 | 3/31/95 | Cosmetic Tote bags containing lipstick and/or eyeshadow; 5/16/95

**FDA notes:** 601(a) | CITROBACTER : FREUNDII; | 601(c) | STAPHYLOCOCCUS : SAPROPHYTICUS; | 601(a); 601(c) | STAPHYLOCOCCUS : SAPROPHYTICUS; CITROBACTER : FREUNDII;

> Prince Chemical Ind Co Ltd Date Published : 09/18/2009 No 12 Hsin Jen Road , Tainan, TAIWAN 53 C - - 03 Eye Shadow (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: 3/31/95 Notes: 601(a) Problems: CITROBACTER : FREUNDII; 53 G - - 05 Lipstick (Makeup Preparations, not for Eyes) Date Published: 09/18/2009 Desc: 3/31/95 Notes: 601(c) Problems: STAPHYLOCOCCUS : SAPROPHYTICUS; 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 09/18/2009 Desc: Cosmetic Tote bags containing lipstick and/or eyeshadow; 5/16/95 Notes: 601(a); 601(c) Problems: STAPHYLOCOCCUS : SAPROPHYTICUS; CITROBACTER : FREUNDII;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Prince Chemical Ind Co Ltd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Ying Piao (Eagle) Industrial Co., Ltd.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TAIWAN

**Address:** 13 Zhong-Xin Rd , Pu Li Zhen , Nan Tou Xian, Nantou TAIWAN

**Date published:** 01/08/2016

**Product code:** 53 C - - 02 Eyeliner (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C.

**Product:** Nikka Notto Express Liquid Waterproof Eyeliner | Nikka Notto Express Liquid Waterproof Eyeliner

**FDA notes:** BURKHOLDERIA : CEPACIA;

> Ying Piao (Eagle) Industrial Co., Ltd. Date Published : 01/08/2016 13 Zhong-Xin Rd , Pu Li Zhen , Nan Tou Xian, Nantou TAIWAN 53 C - - 02 Eyeliner (Eye Makeup Preparations) Date Published: 04/26/2021 Desc: Nikka Notto Express Liquid Waterproof Eyeliner 53 C - - 99 Other Eye Makeup Preparations, N.E.C. Date Published: 01/08/2016 Desc: Nikka Notto Express Liquid Waterproof Eyeliner Problems: BURKHOLDERIA : CEPACIA;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Ying Piao (Eagle) Industrial Co., Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** SUN TEN PHARMACEUTICAL CO., LTD.

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** TAIWAN

**Address:** 3 F , Beixin Rd., Sec. 3; No. 207 Xindian Dist. , New Taipei City Taipei - Special Municip, New Taipei City Taipei - Speci TAIWAN

**Date published:** 02/17/2016

**Product code:** 54 E - - 99 Herbals & Botanical Teas, N.E.C.

**Product:** Red Yeast Rice

**FDA notes:** Product contains lovastatin per FDA analysis.

> SUN TEN PHARMACEUTICAL CO., LTD. Date Published : 02/17/2016 3 F , Beixin Rd., Sec. 3; No. 207 Xindian Dist. , New Taipei City Taipei - Special Municip, New Taipei City Taipei - Speci TAIWAN 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 02/17/2016 Desc: Red Yeast Rice Notes: Product contains lovastatin per FDA analysis.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

SUN TEN PHARMACEUTICAL CO., LTD. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** THAILAND

**Address:** 789/159 Moo 1, Nong Kho-Laemchabang Road , Si Racha, Chonburi THAILAND

**Date published:** 04/05/2012

**Product code:** 53 C - - 03 Eye Shadow (Eye Makeup Preparations)

**Product:** Body Shop Eye Colour 32 Chocolate

**FDA notes:** 601(a) Pseudomonas stutzeri, Acinetobacter Iwoffi, Micrococcus luteus and Moraxella nonliquifaciens

> S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED Date Published : 04/05/2012 789/159 Moo 1, Nong Kho-Laemchabang Road , Si Racha, Chonburi THAILAND 53 C - - 03 Eye Shadow (Eye Makeup Preparations) Date Published: 04/05/2012 Desc: Body Shop Eye Colour 32 Chocolate Notes: 601(a) Pseudomonas stutzeri, Acinetobacter Iwoffi, Micrococcus luteus and Moraxella nonliquifaciens

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Siam Quality Industries Co Ltd

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** THAILAND

**Address:** Sainoi , 49 Moo 1, Bangbuatong-Ladbualuang Road , Sai Noi, Nonthaburi THAILAND

**Date published:** 09/18/2009

**Product code:** 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.

**Product:** Crayon Face Paints; 5/16/06 | Crayon Face Paint; 5/16/06 | Crayon Face Paints; 5/16/06 | Crayon Face Paints; 5/16/06

**FDA notes:** 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;

> Siam Quality Industries Co Ltd Date Published : 09/18/2009 Sainoi , 49 Moo 1, Bangbuatong-Ladbualuang Road , Sai Noi, Nonthaburi THAILAND 53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes) Date Published: 09/18/2009 Desc: Crayon Face Paints; 5/16/06 Notes: 601(a); gram pos spore forming rods; yeast; mold Problems: STAPHYLOCOCCUS : AUREUS; 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) Date Published: 09/18/2009 Desc: Crayon Face Paint; 5/16/06 Notes: 601(a); gram pos spore forming rods; yeast; mold Problems: STAPHYLOCOCCUS : AUREUS; 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 09/18/2009 Desc: Crayon Face Paints; 5/16/06 Notes: 601(a); gram pos spore forming rods; yeast; mold Problems: STAPHYLOCOCCUS : AUREUS; 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 09/18/2009 Desc: Crayon Face Paints; 5/16/06 Notes: 601(a); gram pos spore forming rods; yeast; mold Problems: STAPHYLOCOCCUS : AUREUS;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Siam Quality Industries Co Ltd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** H.C. Herb Club Laboratory

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** THAILAND

**Address:** 91/1 Bangparok , Muang , Pathumthani, THAILAND

**Date published:** 08/02/2018

**Product code:** 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)

**Product:** PAYA Dietary Supplement Product | PAYA Dietary Supplement Product

**FDA notes:** Problem(s); Sibutramine | Problem(s); Sibutramine

> H.C. Herb Club Laboratory Date Published : 08/02/2018 91/1 Bangparok , Muang , Pathumthani, THAILAND 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/02/2018 Desc: PAYA Dietary Supplement Product Notes: Problem(s); Sibutramine 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) Date Published: 08/02/2018 Desc: PAYA Dietary Supplement Product Notes: Problem(s); Sibutramine

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

H.C. Herb Club Laboratory — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Inter Medical Lab AKA Inter Medical Clinic

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** 24-16 Phahonyothin Rd , Lardyao, Jatujak , Bangkok, THAILAND

**Date published:** 09/10/2009

**Product code:** 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

**Product:** Medislim-brand herbal diet pills

**FDA notes:** 1/27/2003

> Inter Medical Lab AKA Inter Medical Clinic Date Published : 09/10/2009 24-16 Phahonyothin Rd , Lardyao, Jatujak , Bangkok, THAILAND 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 09/10/2009 Desc: Medislim-brand herbal diet pills Notes: 1/27/2003

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Inter Medical Lab AKA Inter Medical Clinic — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** International Merchandise Procurement

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** P O Box 336 (Mailing address) , Muang Phuket, Phuket THAILAND

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All prescription drugs

**FDA notes:** 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

> International Merchandise Procurement Date Published : 09/10/2009 P O Box 336 (Mailing address) , Muang Phuket, Phuket THAILAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All prescription drugs Notes: 8/4/1997 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 8/4/1997 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 8/4/1997 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 8/4/1997 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 8/4/1997 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 8/4/1997 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 8/4/1997 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 8/4/1997

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

International Merchandise Procurement — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** MEDICA PHARMA [INC. or CORP.]

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** UNKNOWN , KLONG-CHANG, BANGKOK, THAILAND

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All Prescription Drugs

**FDA notes:** 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

> MEDICA PHARMA [INC. or CORP.] Date Published : 09/10/2009 UNKNOWN , KLONG-CHANG, BANGKOK, THAILAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/05/2021 Desc: All Prescription Drugs Notes: 2/12/2003 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;2/12/2003 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;2/12/2003 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;2/12/2003 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;2/12/2003 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;2/12/2003 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;2/12/2003 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;2/12/2003

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

MEDICA PHARMA [INC. or CORP.] — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** MedicaPharma Corp.

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** 2591 Ladprao101 , Khlong Chan, Bangkapi , Bangkok, THAILAND

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All prescription drugs

**FDA notes:** 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. Date Published : 09/10/2009 2591 Ladprao101 , Khlong Chan, Bangkapi , Bangkok, THAILAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/08/2021 Desc: All prescription drugs Notes: 2/12/2003 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs;2/12/2003 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs;2/12/2003 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs;2/12/2003 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs;2/12/2003 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs;2/12/2003 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs;2/12/2003 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs;2/12/2003

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

MedicaPharma Corp. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** OLAN-KEMED CO., LTD

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** 176 , 16 Lat Phrao Rd , Chatuchak, Bangkok THAILAND

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** :"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

> OLAN-KEMED CO., LTD Date Published : 09/10/2009 176 , 16 Lat Phrao Rd , Chatuchak, Bangkok THAILAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/08/2021 Notes: :"Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products ;2/13/2003 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

OLAN-KEMED CO., LTD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Pa Yang

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** PO Box 8 , Sao Hai, Saraburi THAILAND

**Date published:** 09/10/2009

**Product code:** 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

**FDA notes:** :"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 Date Published : 09/10/2009 PO Box 8 , Sao Hai, Saraburi THAILAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/08/2021 Notes: :"Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products ;2/13/2003 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: "Hemo-Olan" injectable strychnine HCl and all other strychnine injectable products 2/13/2003

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Pa Yang — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Sirirat Maihom (HealthCarePharma)

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** 188 , 122 Saladang Road , Muang Chumphon, Chumphon THAILAND

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All prescription drugs

**FDA notes:** 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

> Sirirat Maihom (HealthCarePharma) Date Published : 09/10/2009 188 , 122 Saladang Road , Muang Chumphon, Chumphon THAILAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/04/2021 Desc: All prescription drugs Notes: 3/5/2002 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/5/2002 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/5/2002 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/5/2002 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/5/2002 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/5/2002 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/5/2002 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/5/2002

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Sirirat Maihom (HealthCarePharma) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Vut, Suthapintu

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** THAILAND

**Address:** P.O. Box 25 , Khlongkum , Bangkok, THAILAND

**Date published:** 09/10/2009

**Product code:** 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

**Product:** All Prescription Drugs

**FDA notes:** 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

> Vut, Suthapintu Date Published : 09/10/2009 P.O. Box 25 , Khlongkum , Bangkok, THAILAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All Prescription Drugs Notes: 8/3/2001 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 8/3/2001 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 8/3/2001 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 8/3/2001 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 8/3/2001 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 8/3/2001 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 8/3/2001 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; 8/3/2001

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Vut, Suthapintu — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Kardesler Ucan Yaglar Sanayi Anonim Sirketi

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TURKEY

**Address:** No:1 Inonu Mahallesi Gebze , Plastikciler Osb. Mahallesi 42 , Gebze, Kocaeli TURKEY

**Date published:** 10/11/2022

**Product code:** 53 A - - 04 Baby Wipes

**Product:** Baby Wipes

**FDA notes:** Gram Positive Rods 601(a) Contaminated with microorganisms

> Kardesler Ucan Yaglar Sanayi Anonim Sirketi Date Published : 10/11/2022 No:1 Inonu Mahallesi Gebze , Plastikciler Osb. Mahallesi 42 , Gebze, Kocaeli TURKEY 53 A - - 04 Baby Wipes Date Published: 10/11/2022 Desc: Baby Wipes Notes: Gram Positive Rods 601(a) Contaminated with microorganisms

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Kardesler Ucan Yaglar Sanayi Anonim Sirketi — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Sapro Temizlik Urunleri Sanayi Ve Ticaret A.s

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** TURKEY

**Address:** No:27 Ortakoy Merkez Mahallesi Ilter Bulvari , Silivri, Istanbul TURKEY

**Date published:** 06/22/2026

**Product code:** 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.

**Product:** 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

**FDA notes:** 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

> Sapro Temizlik Urunleri Sanayi Ve Ticaret A.s Date Published : 06/22/2026 No:27 Ortakoy Merkez Mahallesi Ilter Bulvari , Silivri, Istanbul TURKEY 53 A - - 04 Baby Wipes Date Published: 06/22/2026 Desc: Up & Up Fragrance-Free Baby Wipes Notes: 601(a) Burkholderia cepacia; Burkholderia gladioli 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) Date Published: 06/22/2026 Desc: Up & Up Fragrance-Free Baby Wipes Notes: 601(a) Burkholderia cepacia; Burkholderia gladioli 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 06/22/2026 Desc: Up & Up Fragrance-Free Baby Wipes Notes: 601(a) Burkholderia cepacia; Burkholderia gladioli 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 06/22/2026 Desc: Up & Up Fragrance-Free Baby Wipes Notes: 601(a) Burkholderia cepacia; Burkholderia gladioli 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 06/22/2026 Desc: Up & Up Fragrance-Free Baby Wipes Notes: 601(a) Burkholderia cepacia; Burkholderia gladioli

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Sapro Temizlik Urunleri Sanayi Ve Ticaret A.s — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** ACDC KOZMETIK SANAYI VE TICARET A.S.

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** TURKEY

**Address:** Hal Mah Turgut Ozal Bulvan , Yeni Hal Kompleksi No:24 U Blok 6 , Akdeniz, TR-45 TURKEY

**Date published:** 03/26/2019

**Product code:** 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.

**Product:** 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 notes:** 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

> ACDC KOZMETIK SANAYI VE TICARET A.S. Date Published : 03/26/2019 Hal Mah Turgut Ozal Bulvan , Yeni Hal Kompleksi No:24 U Blok 6 , Akdeniz, TR-45 TURKEY 36 C - - 04 Honey Date Published: 03/26/2019 Desc: Sensual Honey- Herbal Mixed Paste Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil. 36 C - - 99 Honey, N.E.C. Date Published: 03/26/2019 Desc: Sensual Honey- Herbal Mixed Paste Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/26/2019 Desc: Sensual Honey- Herbal Mixed Paste Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 03/26/2019 Desc: Sensual Honey- Herbal Mixed Paste Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 09/20/2019 Desc: Sensual Honey- Herbal Mixed Paste Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil. 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 03/26/2019 Desc: Sensual Honey- Herbal Mixed Paste Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/26/2019 Desc: Sensual Honey- Herbal Mixed Paste Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

ACDC KOZMETIK SANAYI VE TICARET A.S. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** AGROSOL GIDA

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** TURKEY

**Address:** Meric Mahallesi , 5746/4. Sokak No 32 , Bornova, Izmir TURKEY

**Date published:** 11/05/2024

**Product code:** 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.

**Product:** 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 notes:** 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.

> AGROSOL GIDA Date Published : 11/05/2024 Meric Mahallesi , 5746/4. Sokak No 32 , Bornova, Izmir TURKEY 31 K - - 99 Tea, N.E.C. Date Published: 11/05/2024 Desc: HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 11/05/2024 Desc: HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 11/05/2024 Desc: HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. 60 R - - 19 Sibutramine HCL Monohydrate (Anorexic) Date Published: 11/05/2024 Desc: HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 11/05/2024 Desc: HON E LING 100% ALL NATURAL LIBIDO SUPPLEMENT FOR MEN AND WOMEN (HERBAL MACCUN) Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil and Sibutramine.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

AGROSOL GIDA — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Cankatan Food Industry and Trade limited Company

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** TURKEY

**Address:** Evrenkoy Cad. Karanfil Sokak , No: 72/2/A , Ankara, TURKEY

**Date published:** 04/14/2023

**Product code:** 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.

**Product:** Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium

**FDA notes:** Product contains Sildenafil per FDA analysis | Product contains Sildenafil per FDA analysis

> Cankatan Food Industry and Trade limited Company Date Published : 04/14/2023 Evrenkoy Cad. Karanfil Sokak , No: 72/2/A , Ankara, TURKEY 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 04/14/2023 Desc: Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium Notes: Product contains Sildenafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/14/2023 Desc: Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium Notes: Product contains Sildenafil per FDA analysis

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Cankatan Food Industry and Trade limited Company — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** CANKATAN GIDA SANAYI VE TICARETLIM

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** TURKEY

**Address:** 72/2/A Buyukkayacik Osb , Isletim Kayat, TURKEY

**Date published:** 04/14/2023

**Product code:** 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.

**Product:** Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium

**FDA notes:** Product contains Sildenafil per FDA analysis | Product contains Sildenafil per FDA analysis

> CANKATAN GIDA SANAYI VE TICARETLIM Date Published : 04/14/2023 72/2/A Buyukkayacik Osb , Isletim Kayat, TURKEY 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 04/14/2023 Desc: Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium Notes: Product contains Sildenafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/14/2023 Desc: Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium Notes: Product contains Sildenafil per FDA analysis

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

CANKATAN GIDA SANAYI VE TICARETLIM — FDA import alert red lists: firms subject to detention without physical examination