Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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