The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1266-2015·Announced 2015-07-29

Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations

Wockhardt USA is recalling 539 drums of Famotodine Tablets, 20 mg, because the firm did not adequately investigate customer complaints.

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 and involves a CGMP deviation regarding complaint investigation without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Wockhardt USA LLC is recalling 539 drums of Famotodine Tablets, USP, 20 mg, packaged in 6500 count drums for repacking only. The product is Over the Counter and was distributed nationwide in the U.S., including Puerto Rico. The specific lots affected are LN11320 (Expiry: 7/31/2015) and LN11341 (Expiry: 8/31/2015).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact Wockhardt USA LLC for further instructions or a refund.

The recalled product

Product
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
539

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 (4)

  • Lot #: LN11320
  • Expiry: 7/31/2015
  • Lot #: LN11341
  • Expiry: 8/31/2015.

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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