Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), 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) 082815-1, Exp. 06/04/2019; b) 082417-1, Exp. 03/04/2020; 082815-1, Exp. 06/04/2019; c) 082815-1, Exp. 06/04/2019; d) 082815-1, Exp. 06/04/2019

Distribution pattern: Nationwide within USA.