Medroxyprogesterone Acetate USP for prescription compounding recalled over manufacturing violations

Recall date

February 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

American Pharmaceutical Ingredients LLC recalls Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceu…

Recall number

D-0510-2018

FDA classification

Class II

Brand / firm

American Pharmaceutical Ingredients LLC

Sold / distributed

Nationwide within USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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