**Firm:** One World Pharma Pvt. 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:** INDIA

**Address:** 2nd Fl , 201/202/203 Makwana Road , Mumbai, Maharashtra INDIA

**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 finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. | All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm.

> One World Pharma Pvt. Ltd. Date Published : 09/10/2009 2nd Fl , 201/202/203 Makwana Road , Mumbai, Maharashtra INDIA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/09/2021 Notes: All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. 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 finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm. 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All finished dosage prescription drugs not covered by an approved NDA (2/3/2005) receives prescriptions from USA patients, coordinates information regarding procuring prescription drugs and fills the prescriptions with unapproved finished dosage prescription drugs purchased from this firm.

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

One World Pharma Pvt. Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Shah & Shah Intraocular Lens (Pvt) 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:** INDIA

**Address:** 23 Russell Street , Next To 1 J M D H Road Joka 743 512 , Calcutta, INDIA

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

**Product code:** 55 R - - 14 Hydroxypropyl Methylcellulose (Pharmaceutic Necessity - Suspending Agent)

**Product:** Sterile opthalmic hydroxypropyl methylcellulose 2% solution USP for intraocular use

**FDA notes:** 4/7/1995

> Shah & Shah Intraocular Lens (Pvt) Ltd Date Published : 09/10/2009 23 Russell Street , Next To 1 J M D H Road Joka 743 512 , Calcutta, INDIA 55 R - - 14 Hydroxypropyl Methylcellulose (Pharmaceutic Necessity - Suspending Agent) Date Published: 09/10/2009 Desc: Sterile opthalmic hydroxypropyl methylcellulose 2% solution USP for intraocular use Notes: 4/7/1995

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

Shah & Shah Intraocular Lens (Pvt) Ltd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Unicure Remedies Pvt. 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:** INDIA

**Address:** F25 Gorwa , Vadodara, Gujarat INDIA

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

**Product code:** 66 S - - 51 Tadalafil

**Product:** Tadalafil tablets

> Unicure Remedies Pvt. Ltd. Date Published : 09/10/2009 F25 Gorwa , Vadodara, Gujarat INDIA 66 S - - 51 Tadalafil Date Published: 09/10/2009 Desc: Tadalafil tablets

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

Unicure Remedies Pvt. Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Vinay Medical Stores

**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:** INDIA

**Address:** Raja Delux Complex , Nyderabad, INDIA

**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 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995 | All prescription drugs 11/3/1995

> Vinay Medical Stores Date Published : 09/10/2009 Raja Delux Complex , Nyderabad, INDIA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995 56 - - - -- Antibiotics (Human/Animal) Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995 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 11/3/1995 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/1995

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

Vinay Medical Stores — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Wicks Pharmaceuticals Pvt 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:** INDIA

**Address:** Mission Road , Bangalore, INDIA

**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

**Product:** All prescription drugs

**FDA notes:** 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005 | All prescription drugs 11/3/2005

> Wicks Pharmaceuticals Pvt Ltd Date Published : 09/10/2009 Mission Road , Bangalore, INDIA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 02/24/2021 Desc: All prescription drugs Notes: 11/3/2005 56 - - - -- Antibiotics (Human/Animal) Date Published: 09/10/2009 Notes: All prescription drugs 11/3/2005 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 11/3/2005 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/2005 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/2005 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/2005 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/2005 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/2005 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 11/3/2005

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

Wicks Pharmaceuticals Pvt Ltd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** PT Surya Garutindah (Perseroan Terbatas)

**Import alert:** 53-17

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

**Country:** INDONESIA

**Address:** JL Pataruman , No. 47 Garut 44151 , Jawa Barat, INDONESIA

**Date published:** 02/02/2010

**Product code:** 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.

**Product:** All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue)

**FDA notes:** 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

> PT Surya Garutindah (Perseroan Terbatas) Date Published : 02/02/2010 JL Pataruman , No. 47 Garut 44151 , Jawa Barat, INDONESIA 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) Date Published: 08/28/2010 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 53 C - - 99 Other Eye Makeup Preparations, N.E.C. Date Published: 08/28/2010 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 08/28/2010 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

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

PT Surya Garutindah (Perseroan Terbatas) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Hamada Dayateknindo P.T. (aka viagragogo.com)

**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:** INDONESIA

**Address:** Jln. Sangrila Sakti I No. 15 , Jakarta Selatan, Dki Jakarta INDONESIA

**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:** 3/14/2000; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; | All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000;

> Hamada Dayateknindo P.T. (aka viagragogo.com) Date Published : 09/10/2009 Jln. Sangrila Sakti I No. 15 , Jakarta Selatan, Dki Jakarta INDONESIA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All Prescription Drugs Notes: 3/14/2000; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 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; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000; 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).; 3/14/2000;

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

Hamada Dayateknindo P.T. (aka viagragogo.com) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Viagragogo (aka Hamada Dayateknindo, P.T.)

**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:** INDONESIA

**Address:** Jln. Sangrila Sakti I No. 15 , Jakarta Selatan, Dki Jakarta INDONESIA

**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:** 3/14/2000; This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).

> Viagragogo (aka Hamada Dayateknindo, P.T.) Date Published : 09/10/2009 Jln. Sangrila Sakti I No. 15 , Jakarta Selatan, Dki Jakarta INDONESIA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/08/2021 Desc: All Prescription Drugs Notes: 3/14/2000; This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 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 - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 This firm was noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).

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

Viagragogo (aka Hamada Dayateknindo, P.T.) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** USA Medicine.com Ltd. (Mr. Mark Caron)

**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:** IRELAND

**Address:** 123 Sanford Wood , Swords, Dublin IRELAND

**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

> USA Medicine.com Ltd. (Mr. Mark Caron) Date Published : 09/10/2009 123 Sanford Wood , Swords, Dublin IRELAND 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/08/2021 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>

USA Medicine.com Ltd. (Mr. Mark Caron) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** COPPERFIELD EQUINE THERAPY

**Import alert:** 68-19

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

**Country:** IRELAND

**Address:** Copperfield Stuf , Kilfrush, IRELAND

**Date published:** 02/26/2018

**Product code:** 54 F - - 03 Angelica (Herbal & Botanicals, not Teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 70 M - - 02 Horse Mixed Feed Ration | 70 Y - - 99 Animal Feeds, N.E.C.

**Product:** Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement | Copperfield Gold Dietary Supplement

> COPPERFIELD EQUINE THERAPY Date Published : 02/26/2018 Copperfield Stuf , Kilfrush, IRELAND 54 F - - 03 Angelica (Herbal & Botanicals, not Teas) Date Published: 02/26/2018 Desc: Copperfield Gold Dietary Supplement 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 02/26/2018 Desc: Copperfield Gold Dietary Supplement 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/26/2018 Desc: Copperfield Gold Dietary Supplement 70 M - - 02 Horse Mixed Feed Ration Date Published: 02/26/2018 Desc: Copperfield Gold Dietary Supplement 70 Y - - 99 Animal Feeds, N.E.C. Date Published: 02/26/2018 Desc: Copperfield Gold Dietary Supplement

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

COPPERFIELD EQUINE THERAPY — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Israel Pharmacy 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:** ISRAEL

**Address:** Unknown , Petah Tikva, ISRAEL

**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

> Israel Pharmacy Ltd Date Published : 04/18/2016 Unknown , Petah Tikva, ISRAEL 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules 60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic) Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules 60 T - - 15 Naltrexone (Antagonist) Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules

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

Israel Pharmacy Ltd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Magic of Nature c/o Olga Buchman

**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:** ISRAEL

**Address:** P.O. Box 448 , Nes-Tziona, ISRAEL

**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:** 8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001 | All Prescription Drugs;8/9/2001

> Magic of Nature c/o Olga Buchman Date Published : 09/10/2009 P.O. Box 448 , Nes-Tziona, ISRAEL 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/08/2021 Desc: All Prescription Drugs Notes: 8/9/2001 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;8/9/2001 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;8/9/2001 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;8/9/2001 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;8/9/2001 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;8/9/2001 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;8/9/2001 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;8/9/2001

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

Magic of Nature c/o Olga Buchman — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Nezah Israel Pharmacy

**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:** ISRAEL

**Address:** 11 Nezah Israel St , Tel Aviv, ISRAEL

**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

> Nezah Israel Pharmacy Date Published : 04/18/2016 11 Nezah Israel St , Tel Aviv, ISRAEL 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules 60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic) Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules 60 T - - 15 Naltrexone (Antagonist) Date Published: 04/18/2016 Desc: Naltrexone 4.5mg Capsules

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

Nezah Israel Pharmacy — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Arava Pet Spa Ltd.

**Import alert:** 68-19

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

**Country:** ISRAEL

**Address:** 3 Bazlete St. - Mitzpe Sapir Industrial , Tzur Yigal, ISRAEL

**Date published:** 09/29/2023

**Product code:** 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 Y - - 01 Sulfsalazine (Anti-Inflammatory, Part II) | 77 O - - GQ Ear irrigation kit

**Product:** Pet Ear Infections Treatment | Pet Ear Infections Treatment | Pet Ear Infections Treatment | Pet Ear Infections Treatment

> Arava Pet Spa Ltd. Date Published : 09/29/2023 3 Bazlete St. - Mitzpe Sapir Industrial , Tzur Yigal, ISRAEL 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/29/2023 Desc: Pet Ear Infections Treatment 62 G - - 99 Anti-Inflammatory N.E.C. Date Published: 09/29/2023 Desc: Pet Ear Infections Treatment 62 Y - - 01 Sulfsalazine (Anti-Inflammatory, Part II) Date Published: 09/29/2023 Desc: Pet Ear Infections Treatment 77 O - - GQ Ear irrigation kit Date Published: 09/29/2023 Desc: Pet Ear Infections Treatment

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

Arava Pet Spa Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Gamma Croma S.P.A.

**Import alert:** 53-17

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

**Country:** ITALY

**Address:** Km 29 , Strada Statale Paullese 415 , Vaiano Cremasco, Cremona ITALY

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

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

**FDA notes:** Eye shadow | STAPHYLOCOCCUS : HOMINIS; BACILLUS : CEREUS;

> Gamma Croma S.P.A. Date Published : 09/18/2009 Km 29 , Strada Statale Paullese 415 , Vaiano Cremasco, Cremona ITALY 53 C - - 03 Eye Shadow (Eye Makeup Preparations) Date Published: 09/18/2009 Notes: Eye shadow Problems: STAPHYLOCOCCUS : HOMINIS; BACILLUS : CEREUS;

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

Gamma Croma S.P.A. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Anagen (aka DMC di Vezzi Roberto)

**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:** ITALY

**Address:** Via Emilia 30 , Curno, BG ITALY

**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 - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).

> Anagen (aka DMC di Vezzi Roberto) Date Published : 09/10/2009 Via Emilia 30 , Curno, BG ITALY 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 02/12/2021 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 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 - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).

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

Anagen (aka DMC di Vezzi Roberto) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** DMC di Vezzi Roberto (aka anagen.net)

**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:** ITALY

**Address:** Via Emilia 30 , Curno, BG ITALY

**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:** 3/14/2000 ; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).

> DMC di Vezzi Roberto (aka anagen.net) Date Published : 09/10/2009 Via Emilia 30 , Curno, BG ITALY 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All prescription drugs Notes: 3/14/2000 ; The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 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 - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a).

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

DMC di Vezzi Roberto (aka anagen.net) — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Farmacia Cerati di Zambonardi Aldo

**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:** ITALY

**Address:** Via Roma 17 , S Damiano D'Asti, Asti ITALY

**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

> Farmacia Cerati di Zambonardi Aldo Date Published : 09/10/2009 Via Roma 17 , S Damiano D'Asti, Asti ITALY 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>

Farmacia Cerati di Zambonardi Aldo — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Quotaz S. A.

**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:** ITALY

**Address:** Via Cervi # 6 , Palidano, MN ITALY

**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 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991 | All prescription drugs 3/13/1991

> Quotaz S. A. Date Published : 09/10/2009 Via Cervi # 6 , Palidano, MN ITALY 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/10/2009 Notes: All prescription drugs 3/13/1991 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 3/13/1991 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/13/1991 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/13/1991 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/13/1991 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/13/1991 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/13/1991 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs 3/13/1991

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

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


**Firm:** Fatro Spa

**Import alert:** 68-19

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

**Country:** ITALY

**Address:** Via Emilia 285 , Ozzano Dell'Emilia, Bologna ITALY

**Date published:** 07/16/2026

**Product code:** 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 C - - 99 Nutrient/Tonic N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.

**Product:** METABOLASE | METABOLASE | METABOLASE | METABOLASE | METABOLASE | METABOLASE

> Fatro Spa Date Published : 07/16/2026 Via Emilia 285 , Ozzano Dell'Emilia, Bologna ITALY 54 A - - 02 Vitamin B1 (Thiamine) Date Published: 07/16/2026 Desc: METABOLASE 54 A - - 99 Vitamin, N.E.C. Date Published: 07/16/2026 Desc: METABOLASE 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/16/2026 Desc: METABOLASE 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 07/16/2026 Desc: METABOLASE 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/16/2026 Desc: METABOLASE 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 07/16/2026 Desc: METABOLASE

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

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


**Firm:** Daromale International Trading

**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:** JAMAICA

**Address:** 125 Maxfield Ave , Kingston, JAMAICA

**Date published:** 10/26/2020

**Product code:** 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** Black Stallion Bedroom Tonic | Black Stallion Bedroom Tonic | Black Stallion Bedroom Tonic

**FDA notes:** FDA laboratory analysis confirmed product contains Sildenafil. | FDA laboratory analysis confirmed product contains Sildenafil. | FDA laboratory analysis confirmed product contains Sildenafil.

> Daromale International Trading Date Published : 10/26/2020 125 Maxfield Ave , Kingston, JAMAICA 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 10/26/2020 Desc: Black Stallion Bedroom Tonic Notes: FDA laboratory analysis confirmed product contains Sildenafil. 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 10/26/2020 Desc: Black Stallion Bedroom Tonic Notes: FDA laboratory analysis confirmed product contains Sildenafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/26/2020 Desc: Black Stallion Bedroom Tonic Notes: FDA laboratory analysis confirmed product contains Sildenafil.

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

Daromale International Trading — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Ens

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 501 Hanam Venture Center 239 , Gyenonggi-do, KOREA (THE REPUBLIC OF)

**Date published:** 02/03/2016

**Product code:** 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)

**Product:** Green Essence Lifting Facial Mask Pack

**FDA notes:** BACILLUS : CEREUS;

> Ens Date Published : 02/03/2016 501 Hanam Venture Center 239 , Gyenonggi-do, KOREA (THE REPUBLIC OF) 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 02/03/2016 Desc: Green Essence Lifting Facial Mask Pack Problems: BACILLUS : CEREUS;

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

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


**Firm:** Gc Logistics Corporation

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 501 Lohas Ave , Hwaseong, KOREA (THE REPUBLIC OF)

**Date published:** 06/16/2014

**Product code:** 53 C - - 99 Other Eye Makeup Preparations, N.E.C.

**Product:** Eye Toner Panda's Dream Eye Patch

**FDA notes:** Problem; Gram-positive cocci

> Gc Logistics Corporation Date Published : 06/16/2014 501 Lohas Ave , Hwaseong, KOREA (THE REPUBLIC OF) 53 C - - 99 Other Eye Makeup Preparations, N.E.C. Date Published: 06/16/2014 Desc: Eye Toner Panda's Dream Eye Patch Notes: Problem; Gram-positive cocci

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

Gc Logistics Corporation — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Greenb Cosmetic Co. Ltd.

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 147 Block 8 Namdong Industrial Complex , 713-16 Gojan-Dong , Incheon, KOREA (THE REPUBLIC OF)

**Date published:** 06/04/2014

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

**Product:** Mascara

**FDA notes:** Candida pelliculosa Aerobic plate count Yeast and Mold | STAPHYLOCOCCUS : AUREUS; CANDIDA;

> Greenb Cosmetic Co. Ltd. Date Published : 06/04/2014 147 Block 8 Namdong Industrial Complex , 713-16 Gojan-Dong , Incheon, KOREA (THE REPUBLIC OF) 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 06/04/2014 Desc: Mascara Notes: Candida pelliculosa Aerobic plate count Yeast and Mold Problems: STAPHYLOCOCCUS : AUREUS; CANDIDA;

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

Greenb Cosmetic Co. Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** H & K Korea Corp.

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** No. 307 3f Woori Bldg. 47-17 Sin , Seoul, KOREA (THE REPUBLIC OF)

**Date published:** 01/18/2013

**Product code:** 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.

**Product:** Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch | Hydrogel Eye Patch

**FDA notes:** 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. | 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

> H & K Korea Corp. Date Published : 01/18/2013 No. 307 3f Woori Bldg. 47-17 Sin , Seoul, KOREA (THE REPUBLIC OF) 53 C - - 04 Eye Lotion (Eye Makeup Preparations) Date Published: 01/18/2013 Desc: Hydrogel Eye Patch Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) Date Published: 01/18/2013 Desc: Hydrogel Eye Patch Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. 53 C - - 99 Other Eye Makeup Preparations, N.E.C. Date Published: 01/18/2013 Desc: Hydrogel Eye Patch Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 01/18/2013 Desc: Hydrogel Eye Patch Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/18/2013 Desc: Hydrogel Eye Patch Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/18/2013 Desc: Hydrogel Eye Patch Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis. 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 01/18/2013 Desc: Hydrogel Eye Patch Notes: 601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

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

H & K Korea Corp. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Pacific Corporation

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** CPO Box 195 , Seoul, KOREA (THE REPUBLIC OF)

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

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

**Product:** eye shadow; 5/16/95

**FDA notes:** 601(a) | PSEUDOMONAS : STUTZERI;

> Pacific Corporation Date Published : 09/18/2009 CPO Box 195 , Seoul, KOREA (THE REPUBLIC OF) 53 C - - 03 Eye Shadow (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: eye shadow; 5/16/95 Notes: 601(a) Problems: PSEUDOMONAS : STUTZERI;

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

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


**Firm:** Seowoo Int Corp

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 3 Ga Chungjeong-Ro, Seodaemun-gu , 229 Chungdong , Seoul, Seoul KOREA (THE REPUBLIC OF)

**Date published:** 02/02/2010

**Product code:** 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.

**Product:** All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue)

**FDA notes:** 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

> Seowoo Int Corp Date Published : 02/02/2010 3 Ga Chungjeong-Ro, Seodaemun-gu , 229 Chungdong , Seoul, Seoul KOREA (THE REPUBLIC OF) 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) Date Published: 08/28/2010 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 53 C - - 99 Other Eye Makeup Preparations, N.E.C. Date Published: 04/01/2021 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 08/28/2010 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

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

Seowoo Int Corp — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** TONYMOLY Co., Ltd.

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 180 Bangbae-ro , Seoco-gu, Seoulteugbyeol-si KOREA (THE REPUBLIC OF)

**Date published:** 06/16/2014

**Product code:** 53 C - - 99 Other Eye Makeup Preparations, N.E.C.

**Product:** Eye Toner Panda's Dream Eye Patch

**FDA notes:** Gram-positive cocci

> TONYMOLY Co., Ltd. Date Published : 06/16/2014 180 Bangbae-ro , Seoco-gu, Seoulteugbyeol-si KOREA (THE REPUBLIC OF) 53 C - - 99 Other Eye Makeup Preparations, N.E.C. Date Published: 06/16/2014 Desc: Eye Toner Panda's Dream Eye Patch Notes: Gram-positive cocci

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

TONYMOLY Co., Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** VOTRE COSMETIC CO,. LTD

**Import alert:** 53-17

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 71 Mayu-Ro 186 Beon-Gil , Gyeonggi-Do, KOREA (THE REPUBLIC OF)

**Date published:** 02/07/2020

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

**Product:** Mascara Falscara

**FDA notes:** Violative for APC and Yeast & Mold

> VOTRE COSMETIC CO,. LTD Date Published : 02/07/2020 71 Mayu-Ro 186 Beon-Gil , Gyeonggi-Do, KOREA (THE REPUBLIC OF) 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 02/07/2020 Desc: Mascara Falscara Notes: Violative for APC and Yeast & Mold

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

VOTRE COSMETIC CO,. LTD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Dae Han Corporation

**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:** KOREA (THE REPUBLIC OF)

**Address:** Bundang-Gu , 703 Sungwoo Starus, 16 Gumi-Ro , Seongnam-si, KYONGGi KOREA (THE REPUBLIC OF)

**Date published:** 06/30/2015

**Product code:** 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

**Product:** Power Khan Pills

**FDA notes:** Undeclared Sulfoaildenafil and Acetildenafil

> Dae Han Corporation Date Published : 06/30/2015 Bundang-Gu , 703 Sungwoo Starus, 16 Gumi-Ro , Seongnam-si, KYONGGi KOREA (THE REPUBLIC OF) 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/30/2015 Desc: Power Khan Pills Notes: Undeclared Sulfoaildenafil and Acetildenafil

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

Dae Han Corporation — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** SamjinPharm

**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:** KOREA (THE REPUBLIC OF)

**Address:** 338-8 Seokyo-dong , Mapo-ku , Seoul, KOREA (THE REPUBLIC OF)

**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; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01 | All prescription drugs; 4/30/01

> SamjinPharm Date Published : 09/10/2009 338-8 Seokyo-dong , Mapo-ku , Seoul, KOREA (THE REPUBLIC OF) 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/10/2009 Notes: All prescription drugs; 4/30/01 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; 4/30/01 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 4/30/01 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 4/30/01 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 4/30/01 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 4/30/01 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 4/30/01 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs; 4/30/01

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

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


**Firm:** NATURAL PRO CO.,LTD.

**Import alert:** 68-19

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

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 17-2 Yeouidonggil17beon-Gil , Jeongnam-Myeon , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF)

**Date published:** 09/08/2023

**Product code:** 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 70 E - - 09 Vitamins | 72 B - - 99 Pet Dog Food N.E.C. | 72 B - - 99 Pet Dog Food N.E.C. | 72 B - - 99 Pet Dog Food N.E.C.

**Product:** NOCK Probiotics Dental Support | NOCK Probiotics Kidney Support | NOCK Probiotics Respiratory Support | NOCK Probiotics Kidney Support | NOCK Probiotics Dental Support | NOCK Probiotics Respiratory Support

> NATURAL PRO CO.,LTD. Date Published : 09/08/2023 17-2 Yeouidonggil17beon-Gil , Jeongnam-Myeon , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) 70 E - - 09 Vitamins Date Published: 09/08/2023 Desc: NOCK Probiotics Dental Support 70 E - - 09 Vitamins Date Published: 09/08/2023 Desc: NOCK Probiotics Kidney Support 70 E - - 09 Vitamins Date Published: 09/08/2023 Desc: NOCK Probiotics Respiratory Support 72 B - - 99 Pet Dog Food N.E.C. Date Published: 09/08/2023 Desc: NOCK Probiotics Kidney Support 72 B - - 99 Pet Dog Food N.E.C. Date Published: 09/08/2023 Desc: NOCK Probiotics Dental Support 72 B - - 99 Pet Dog Food N.E.C. Date Published: 09/08/2023 Desc: NOCK Probiotics Respiratory Support

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

NATURAL PRO CO.,LTD. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Con Tech Korea Co. Ltd.

**Import alert:** 86-11

**Import alert name:** "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination"

**Country:** KOREA (THE REPUBLIC OF)

**Address:** Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA (THE REPUBLIC OF)

**Date published:** 06/16/2014

**Product code:** 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight

**Product:** Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses

> Con Tech Korea Co. Ltd. Date Published : 06/16/2014 Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA (THE REPUBLIC OF) 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 06/16/2014 Desc: Contact Lenses 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 06/16/2014 Desc: Contact Lenses 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 06/16/2014 Desc: Contact Lenses 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 06/16/2014 Desc: Contact Lenses 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 06/16/2014 Desc: Contact Lenses 86 M - - VN Lens, Contact (Disposable) Date Published: 06/16/2014 Desc: Contact Lenses 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 06/16/2014 Desc: Contact Lenses 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 06/16/2014 Desc: Contact Lenses 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 06/16/2014 Desc: Contact Lenses 86 N - - UU Lens, Contact, Orthokeratology, Overnight Date Published: 06/16/2014 Desc: Contact Lenses

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1133.html>

Con Tech Korea Co. Ltd. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Contech Korea

**Import alert:** 86-11

**Import alert name:** "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination"

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 970-14 Wolchul-Dong , Gwangju, KOREA (THE REPUBLIC OF)

**Date published:** 06/16/2014

**Product code:** 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight

**Product:** Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses

> Contech Korea Date Published : 06/16/2014 970-14 Wolchul-Dong , Gwangju, KOREA (THE REPUBLIC OF) 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 06/16/2014 Desc: Contact Lenses 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 06/16/2014 Desc: Contact Lenses 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 06/16/2014 Desc: Contact Lenses 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 06/16/2014 Desc: Contact Lenses 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 06/16/2014 Desc: Contact Lenses 86 M - - VN Lens, Contact (Disposable) Date Published: 06/16/2014 Desc: Contact Lenses 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 06/16/2014 Desc: Contact Lenses 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 06/16/2014 Desc: Contact Lenses 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 06/16/2014 Desc: Contact Lenses 86 N - - UU Lens, Contact, Orthokeratology, Overnight Date Published: 06/16/2014 Desc: Contact Lenses

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1133.html>

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