Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), 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) 111516-1, Exp. 09/19/2018; b) 011917A-1, Exp. 09/22/2018; c) 111516-1, Exp. 09/19/2018; d) 011917A-1, Exp. 09/22/2018; 111516-1, Exp. 09/19/2018; e) 011917A-1, Exp. 09/22/2018; 111516-1, Exp. 09/19/2018

Distribution pattern: Nationwide within USA.