American Pharmaceutical Ingredients LLC recalls Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceut
Recalled February 28, 2018 · FDA recall D-0510-2018 · 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
12000 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
Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8
Manufacturer(s)
American Pharmaceutical Ingredients LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →