Ketoconazole USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Ketoconazole USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.
- Product
- Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Category
- Drug
- Distribution
- Distributed nationwide