Methocarbamol recalled over manufacturing violations

Recall date

May 26, 2017

Source

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

Official notice title

American Pharmaceutical Ingredients LLC recalls Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000…

Recall number

D-0937-2017

FDA classification

Class II

Brand / firm

American Pharmaceutical Ingredients LLC

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Lack of quality assurance at the API manufacturer.

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

What was recalled

Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327