The Recall Desk
ModerateFDA (Drugs)·D-1263-2015·Announced 2015-07-29

Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg 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, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. The specific deviation is a failure to investigate complaints, which is a procedural quality control issue rather than a direct physical hazard like contamination or mislabeling of an allergen.

Plain-English summary

Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg, which are available in 30-count bottles and 3 x 3 tablet card cartons. The product is prescription-only and was distributed nationwide in the United States, including Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lots include various expiration dates ranging from April 2015 to July 2016.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Antibiotic
Hazard

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)

  • A) Lot #: LM10739
  • Expiry: 4/30/2015
  • Lot #: LM10991
  • Expiry: 5/31/2015
  • Lot #: LM11264
  • Expiry: 6/30/2015
  • Lot #: LM12019
  • Expiry: 11/30/2015
  • Lot #: LN10100
  • Expiry: 12/31/2015
  • Lot #: LN10220
  • Lot #: LN10227
  • Lot #: LN10228
  • Lot #: LN11405
  • Expiry: 9/30/2016. B) Lot #: LM11015
  • Lot #: LM11609
  • Expiry: 9/30/2015
  • Lot #: LM11883
  • Expiry: 10/31/2015
  • Lot #: LM11918

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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