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

Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Code information: Lot: #:a) 083017-1, Exp. 7/22/2022; b) 083017-1, Exp. 7/22/2022; c) 083017-1, Exp. 7/22/2022.

Distribution pattern: Nationwide within USA.