May 2023 FDA Recall Famotidine by Glenmark Therapeutics, Inc.
D-0939-2023 - Labeling
This Class II drug recall was voluntarily initiated by Glenmark Therapeutics, Inc. on May 1, 2023 for the product Famotidine. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0939-2023
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.
05-01-2023
07-26-2023
19,968 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Therapeutics, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
09-17-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
