The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1265-2015·Announced 2015-07-29

Wockhardt Recalls Famotodine Tablets Due to Complaint Investigation Failures

Wockhardt USA is recalling Famotodine Tablets 20 mg because the company did not adequately investigate customer complaints, a CGMP deviation.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 adverse health consequences. The specific hazard is a CGMP deviation regarding complaint investigation, which is a procedural failure rather than a direct physical or chemical hazard like contamination or mislabeling with immediate health risks.

Plain-English summary

Wockhardt USA Inc. is recalling Famotodine Tablets, USP, 20 mg, which are packaged in 30, 100, and 1000-count bottles. The product is distributed nationwide in the United States, including Puerto Rico. The recall involves specific lot numbers with expiration dates ranging from April 2015 to September 2016.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This failure to properly investigate complaints is a regulatory compliance issue that necessitates the recall of the affected drug products.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor. Patients should consult their healthcare provider for alternative treatment options if they have been using the recalled medication.

The recalled product

Product
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Tablets
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 #: LM10708
  • Expiry: 4/30/2015
  • Lot #: LM10859
  • Expiry: 5/31/2015
  • Lot #: LM11200
  • Expiry: 7/31/2015
  • Lot #: LM11679
  • Expiry: 9/30/2015
  • Lot #: LN10465
  • Expiry: 1/31/2016
  • Lot #: LN10750
  • Expiry: 3/31/2016
  • Lot #: LN11385
  • Expiry: 9/30/2016. B) Lot #: LM10709
  • Lot #: LM10719
  • Lot #: LM10721
  • Lot #: LM10827
  • Lot #: LM10828
  • Lot #: LM10912
  • Lot #: LM11205

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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