US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 22, 2015 (11 years ago)

Clarithromycin Tablets

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

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

What was recalled

Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.

Recalling firm
Wockhardt Usa Inc.
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1249-2015

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 Clarithromycin recalls

See all
Class II · Moderate risk Terminated

Clarithromycin tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-437-11 D-1224-2015
Class II · Moderate risk Terminated

Clarithromycin Tablets

Reason 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

Blenheim Pharmacal, Inc. NDC 10544-522-20 D-1110-2015
Class II · Moderate risk Terminated

Clarithromycin active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-592-2015
Class II · Moderate risk Terminated

triple therapy

Reason Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

Teva Pharmaceuticals USA NDC 0093-8055-78 D-1499-2014