American Pharmaceutical Ingredients LLC recalls Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC

Recalled February 28, 2018 · FDA recall D-0521-2018 · 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

10000 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

Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.

Manufacturer(s)

American Pharmaceutical Ingredients LLC

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