The Recall Desk
ModerateFDA (Drugs)·D-1249-2015·Announced 2015-07-29

Wockhardt Recalls Clarithromycin Tablets Due to Complaint Investigation Failures

Wockhardt USA is recalling 59,729 bottles of Clarithromycin 500 mg tablets because the firm did not adequately investigate customer complaints.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations regarding complaint investigation, which fits the rubric for moderate severity involving procedural or labeling issues without reported serious injury.

Plain-English summary

Wockhardt USA Inc. is recalling 59,729 bottles of Clarithromycin Tablets, USP, 500 mg. The product is distributed nationwide in the United States, including Puerto Rico. The tablets are prescription-only and are manufactured by Wockhardt Limited in Mumbai, India.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm failed to adequately investigate customer complaints. The affected lots include LM11172, LN10487, LN10488, LN10489, LN10578, LN10581, LN10582, LN11068, LN11073, LN11125, LN11362, LN11379, and LN11380, with expiration dates ranging from June 30, 2015, to August 31, 2016.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
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.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Antibiotic
Hazard
Affected units
59,729

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: LM11172
  • Expiry: 6/30/2015
  • Lot #: LN10487
  • Expiry: 1/31/2016
  • Lot #: LN10488
  • Lot #: LN10489
  • Expiry: 2/29/2016
  • Lot #: LN10578
  • Lot #: LN10581
  • Lot #: LN10582
  • Lot #: LN11068
  • Expiry: 4/30/2016
  • Lot #: LN11073
  • Lot #: LN11125
  • Expiry: 5/31/2016
  • Lot #: LN11362
  • Expiry: 8/31/2016
  • Lot #: LN11379
  • Lot #: LN11380
  • Expiry: 8/31/2016.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 35 recalled by Wockhardt Usa Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 35 products in this recall →

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