Famotidine Tablet, Film Coated
FDA Recall NDC 72657-113
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Famotidine (NDC 72657-113). A significant event, classified as Class II, was initiated on May 01, 2023 by Glenmark Therapeutics Inc., Usa. The reported reason for this action was: "Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
May 01, 2023
Jul 26, 2023
19,968 bottles
Recall Profile & Regulatory Data
Event ID
92565
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Therapeutics, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 17, 2024
Product Description
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Batch or Lot Expiration Information
Lot# FA2022001B, Exp 03/2025
Affected Packages Involved in this Recall
72657-112-90Product
72657-112-20Product
72657-113-88Product
72657-113-20Product
72657-132-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
