Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), 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) 020717-3, Exp. 12/31/2021; b) 020717-2 020717-4, 020717-5 Exp. 12/31/2021; 092816-2, 092816-3, Exp. 07/31/2021; 121015-4, 121015-5, 121015-6, Exp.10/31/2020; c) 020717-1, 020717-4, 020717-5, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 092816-2, Exp. 07/31/2021; 121015-1,121015-3, Exp. 10/31/2020; d) 020717-1, 020717-2, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 121015-2, Exp. 10/31/2020; e) 020717-1,020717-2 Exp. 12/31/2021.

Distribution pattern: Nationwide within USA.