Glenmark Therapeutics, Inc. recalls Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwa

Recalled July 26, 2023 · FDA recall D-0939-2023 · Glenmark Therapeutics

Hazard

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. · FDA Class II

Units

19,968 bottles

Sold at

Nationwide in the USA

Description

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.

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.

Manufacturer(s)

Glenmark Therapeutics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →