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

Recall date

May 1, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0939-2023

FDA classification

Class II

Brand / firm

Glenmark Therapeutics, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.