American Pharmaceutical Ingredients LLC recalls Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g

Recalled February 28, 2018 · FDA recall D-0514-2018 · American Pharmaceutical Ingredients

Hazard

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

Units

24025 g

Sold at

Nationwide within USA.

Description

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

Product

Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Manufacturer(s)

American Pharmaceutical Ingredients LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →