American Pharmaceutical Ingredients LLC recalls Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 5859

Recalled February 28, 2018 · FDA recall D-0477-2018 · 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

10 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

Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 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 →