Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Clarithromycin Tablets Recalled by Blenheim Pharmacal, Inc. Due to cGMP Deviations; products being recalled in response to...

Date: May 22, 2015
Company: Blenheim Pharmacal, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Blenheim Pharmacal, Inc. directly.

Affected Products

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

Quantity: 50 bottles

Why Was This 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

Where Was This Sold?

Indiana

About Blenheim Pharmacal, Inc.

Blenheim Pharmacal, Inc. has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report