Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), 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) 081015-1, Exp 07/23/2018; b) 081015-1, Exp 07/23/2018; 111116-1, Exp. 10/05/2019; c) 081015-1, Exp. 07/23/2018; 111116-1, Exp. 10/05/2019

Distribution pattern: Nationwide within USA.