FDA Recalls Estriol USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Estriol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support expiration dates.
- Product
- Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327.
- Category
- Drug
- Distribution
- Distributed nationwide