FARMAK PRAT · 66-41 · UKRAINE
For FARMAK PRAT · 66-41 · UKRAINE, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is UKRAINE; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 61 M - - 31 Phenobarbital (Anti-Convulsant); date published is 09/30/2009; address is Bud 63 Vul. Kyrylivska , Kyiv, Kyiv UKRAINE, verified against its source on 2026-09-16.
- Firm
- FARMAK PRAT verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- UKRAINE verified
- Address
- Bud 63 Vul. Kyrylivska , Kyiv, Kyiv UKRAINE verified
- Date published
- 09/30/2009 verified
- Product code
- 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 61 M - - 31 Phenobarbital (Anti-Convulsant) each item verified
- FDA notes
- 8/24/2007. Corvalol. Korvalol. Covalolum. Detentions of this product should use the 502(f)(1) misbranding charge. FDA has determined that the Corvalol product contains undeclared phenobarbital. The agency is aware that the product is being sold Over the Counter (OTC) in Eastern European American communities for the treatment of angina; chest pains and as a sedative. This product is not approved for OTC use in the US FDA previously issued a health hazzard alert for Corvalol on July 28 1997. | 8/24/2007. Corvalol. Korvalol. Covalolum. Detentions of this product should use the 502(f)(1) misbranding charge. FDA has determined that the Corvalol product contains undeclared phenobarbital. The agency is aware that the product is being sold Over the Counter (OTC) in Eastern European American communities for the treatment of angina; chest pains and as a sedative. This product is not approved for OTC use in the US FDA previously issued a health hazzard alert for Corvalol on July 28 1997. each item verified
What the source says
FARMAK PRAT Date Published : 09/30/2009 Bud 63 Vul. Kyrylivska , Kyiv, Kyiv UKRAINE 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/30/2009 Notes: 8/24/2007. Corvalol. Korvalol. Covalolum. Detentions of this product should use the 502(f)(1) misbranding charge. FDA has determined that the Corvalol product contains undeclared phenobarbital. The agency is aware that the product is being sold Over the Counter (OTC) in Eastern European American communities for the treatment of angina; chest pains and as a sedative. This product is not approved for OTC use in the US FDA previously issued a health hazzard alert for Corvalol on July 28 1997. 61 M - - 31 Phenobarbital (Anti-Convulsant) Date Published: 09/30/2009 Notes: 8/24/2007. Corvalol. Korvalol. Covalolum. Detentions of this product should use the 502(f)(1) misbranding charge. FDA has determined that the Corvalol product contains undeclared phenobarbital. The agency is aware that the product is being sold Over the Counter (OTC) in Eastern European American communities for the treatment of angina; chest pains and as a sedative. This product is not approved for OTC use in the US FDA previously issued a health hazzard alert for Corvalol on July 28 1997.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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