drugs Class II Updated 2018-02-28

American Pharmaceutical Ingredients LLC recalls Testosterone (Soy) (Micronized) USP for prescription compoun

Recalled Product

Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Hazard / Issue

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) 071516-3, Exp. 04/01/2019; b) 071516-3, Exp. 4/1/2019; c) 071516-1, 071516-2, Exp. 04/01/2019; d) 071516-1, 071516-3, Exp. 04/01/2019, 032117B-1, Exp. 2/9/2020.
View official government recall

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