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WARNING LETTER
•www.buynetmeds.com

www.buynetmeds.com – FDA Warning Letter

Record Details

On June 12, 2025, the FDA issued a Warning Letter to www.buynetmeds.com (India) for unlawfully selling unapproved and misbranded drugs to U.S. consumers via the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The website was found to be introducing unapproved and misbranded opioid drug products (specifically tapentadol, sold under various brand names like Asmanol, Aspadol, Etadol, etc.) and semaglutide drug products, including injectable versions (marketed as Rybelsus and Fitaro). These products are considered "new drugs" under section 201(p) of the FD&C Act because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a).

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for layperson use, as they are prescription drugs requiring professional supervision. The website also offers these prescription drugs without requiring a prescription, violating sections 503(b)(1) and 301(

Company
www.buynetmeds.com
Product type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Sangeeta V. Chatterjee
View Company Profile

ID · 9df3ecca-6eb6-4cfe-bad6-7f9ae82cab1a

Violation Codes8
21 U.S.C. 331(k)21 U.S.C. 355(a)21 CFR 201.115(a)21 CFR 201.521 CFR 201.12821 U.S.C. 331(a)21 U.S.C. 353(b)21 U.S.C. 331(d)

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Other documents for www.buynetmeds.com
  • WARNING_LETTER - 2025-07-01July 1, 2025

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