Clarithromycin Tablets recalled over manufacturing violations

Recall date

May 22, 2015

Source

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

Official notice title

Blenheim Pharmacal, Inc. recalls Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged…

Recall number

D-1110-2015

FDA classification

Class II

Brand / firm

Blenheim Pharmacal, Inc.

Sold / distributed

Indiana

Why it was recalled

cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

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

What was recalled

Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02