Oxandrolone USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Oxandrolone USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.
- Product
- Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Category
- Drug
- Distribution
- Distributed nationwide