The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1250-2015·Announced 2015-07-29

Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations

Wockhardt USA Inc. is recalling Famotodine Tablets, USP, 40 mg due to inadequate investigation of 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 Inc. is recalling Famotodine Tablets, USP, 40 mg, which are packaged in 30, 100, and 1000 count bottles. The product is prescription-only and was distributed nationwide in the United States, including Puerto Rico.

The recall was initiated because the firm did not adequately investigate customer complaints, which constitutes a Current Good Manufacturing Practice (CGMP) deviation. The FDA has classified this recall as Class II.

Consumers with this medication should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
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 #: LM10806
  • Expiry: 5/31/2015
  • Lot #: LM11099
  • Expiry: 6/30/2015
  • Lot #: LM11297
  • Expiry: 7/31/2015
  • Lot #: LM11933
  • Expiry: 10/31/2015
  • Lot #: LN10180
  • Expiry: 12/31/2015
  • Lot #: LN10547
  • Expiry: 2/29/2016. B) Lot #: LM10784
  • Lot #: LM10791
  • Lot #: LM10812
  • Lot #: LM11112
  • Lot #: LM11298
  • Lot #: LM11299
  • Lot #: LM11625
  • Expiry: 8/31/2015
  • Lot #: LN10182

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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