Drug recall D-0939-2023

Class II Terminated reported Jul 26, 2023

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.

Reason for recall

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.

Lots and codes

FA2022001B, Exp 03/2025

Recall details

Recalling firm
Glenmark Therapeutics, Inc., Mahwah, NJ
Quantity
19,968 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 1, 2023
Terminated
September 17, 2024

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