Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product 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 the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug. Distribution: Product distributed nationwide within the United States. Quantity: 11500 boxes Lot/code info: Lot #: 2108, Exp. Date 10/31/2024.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.