Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Reason for recall: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug. Distribution: Product distributed nationwide within the United States. Quantity: 7000 boxes Lot/code info: Lot #: BTH:230551, Exp. Date 12.05.2026; BTH:230571, Exp. Date 14.05.2026
Official record: FDA (Drug enforcement) ↗
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