Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), 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) 102015-3, Exp. 07/31/2020; 081616-3R, Exp. 02/28/2021; b) 081616-3, 081616-3R, Exp. 02/28/2021; 102015-2, Exp. 07/31/2020; c) 081616-1R, Exp. 02/28/2021; 081616-1, Exp. 02/29/2021; 102015-1, 102015-2, Exp. 07/31/2020; d) 102015-1, Exp. 07/31/2020; 081616-1, Exp. 02/29/2021; 081616-1R, 081616-2R, Exp. 02/28/2021.

Distribution pattern: Nationwide within USA.