FDA Recalls Vardenafil HCl for Prescription Compounding Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Vardenafil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
- Product
- Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48
- Category
- Drug
- Distribution
- Distributed nationwide