Progesterone 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 Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 585…

Recall number

D-0518-2018

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

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327