Reported Jul 29, 2015 · Terminated

Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai,…

Wockhardt USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271

Is this the product you have?

  • Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only
  • Manufactured byWockhardt Limited, Mumbai, India
  • Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
  • NDC64679-949-01
Lot codes and dates

13 of 13 products

Products covered by this recall
#Product as published
1LM11172, Expiry: 6/30/2015
2Lot #: LN10487, Expiry: 1/31/2016
3Lot #: LN10488, Expiry: 1/31/2016
4Lot #: LN10489, Expiry: 2/29/2016
5Lot #: LN10578, Expiry: 2/29/2016
6Lot #: LN10581, Expiry: 2/29/2016
7Lot #: LN10582, Expiry: 2/29/2016
8Lot #: LN11068, Expiry: 4/30/2016
9Lot #: LN11073, Expiry: 4/30/2016
10Lot #: LN11125, Expiry: 5/31/2016
11Lot #: LN11362, Expiry: 8/31/2016
12Lot #: LN11379, Expiry: 8/31/2016
13Lot #: LN11380, Expiry: 8/31/2016.
Amount recalled
59,729 Bottles

This recall covers 35 products

The agency filed one notice per product. You are reading one of them; the other 34 are below.

22 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 9, 2018 · Data as of Sep 19, 5:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.