American Pharmaceutical Ingredients LLC recalls Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g

Recalled February 28, 2018 · FDA recall D-0478-2018 · 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

48525 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

Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), 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 →