FDA WARNING_LETTER - tvforever

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Record Details

The FDA issued a Warning Letter to the operator of michaelpharmacy.com, mywebmarquee.com, pharmazero.com, and pharmalove.com for offering violative drug products for sale. The products include "Accutane," "Acomplia," "Zimulti," "Valium," "Xanax," "Ativan," "Vicodin ES," "Lunesta," and "SleepWell (Herbal Xanax)."

The violations fall into two main categories:

1. **Unapproved New Drugs:** Products like "Acomplia," "Zimulti," and "SleepWell (Herbal Xanax)" are considered "new drugs" under Section 201(p) of the Act and are being introduced into interstate commerce without FDA-approved applications, violating Sections 301(d) and 505(a). "Acomplia" (Rimonabant) was specifically rejected by the FDA due to safety concerns. "SleepWell (Herbal Xanax)" is also an unapproved new drug, and its name misleadingly suggests it contains the approved drug Xanax.

2. **Misbranded Drugs:** * Products such as "Accutane," "Valium," "Xanax," "Ativan," "Vicodin ES," and "Lunesta" are offered for sale without requiring a prescription from a licensed practitioner, violating Section 503(

Company: tvforever
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Deborah M. Autor (Former FDA Deputy Commissioner)

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ID · 5b463124-7fc8-4346-b230-2d941694d6de

Violation Codes10

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(f)(1)21 U.S.C. 352(a)

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