FDA Recalls Tretinoin USP for Prescription Compounding Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Tretinoin USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned expiration dates.
- Product
- Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Category
- Drug
- Distribution
- Distributed nationwide