US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 9, 2018 (9 years ago)

Baclofen USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

What was recalled

Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

Recalling firm
American Pharmaceutical Ingredients LLC
NDC code
58597-8004-4
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0476-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Baclofen recalls

See all
Class II · Moderate risk Ongoing

Baclofen Tablets USP

Reason Presence of Foreign Tablets/Capsules

Golden State Medical Supply Inc. NDC 51407-973-10 D-0235-2026