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WARNING LETTER
•onlinepharmacyy.com@proxy.dreamhost.com

onlinepharmacyy.com@proxy.dreamhost.com – FDA Warning Letter

Record Details

The FDA issued a Warning Letter to onlinepharmacyy.com for offering products in violation of the Federal Food, Drug, and Cosmetic Act. The website sells drugs like "Xanax (Generic)," "Valium (Brand)," "Viagra (Brand)," "Prozac (Generic)," "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," and "Herbal Xanax."

The violations include marketing unapproved new drugs, specifically "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," and "Herbal Xanax," which are defined as "new drugs" under section 201(p) of the Act. Rimonabant (Acomplia) was previously rejected by the FDA due to safety concerns. "Herbal Xanax" is also considered a new drug due to its intended use and name. The sale of these without FDA-approved applications violates sections 301(d) and 505(a).

Additionally, several products, including "Xanax (Generic)," "Valium (Brand)," "Viagra (Brand)," and "Prozac (Generic)," are misbranded under section 503(b)(1) because they are sold without requiring a prescription, and some are controlled substances. The website also falsely claims FDA approval for its products, making them misbranded under section 502(a). "Herbal

Company
onlinepharmacyy.com@proxy.dreamhost.com
Product type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Deborah M. Autor (Former FDA Deputy Commissioner)
View Company Profile

ID · c7f177ee-be0c-4a0c-9599-702a8b0b7bc6

Violation Codes9
21 U.S.C. 353(b)(1)21 U.S.C. 321(g)21 U.S.C. 331(a)21 U.S.C. 321(p)21 U.S.C. 331(d)21.U.S.C. 355(a)21 U.S.C. 331(b)21 U.S.C. 331(k)21 U.S.C. 352(a)

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