FDA Recalls Estradiol Hemihydrate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Estradiol Hemihydrate USP for prescription compounding because it lacks stability data to support its expiration date.
- Product
- Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Category
- Drug
- Distribution
- Distributed nationwide