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Maypharm was cited for introducing unapproved and misbranded botulinum toxin (Botox) injectable drug products into U.S. interstate commerce through its website (www.maypharm.net), violating sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain FDA approval for these new drugs prior to marketing them and did not ensure proper labeling as required by law. The FDA emphasized that unapproved injectable drugs pose serious safety risks to consumers, including potential contamination, counterfeit formulations, inconsistent active ingredient levels, and life-threatening conditions such as sepsis, and requested immediate cessation of sales to U.S. consumers.