FDA-Drug2023-07-26Class II
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.
Glenmark Therapeutics, Inc.
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.
Sold states
Nationwide in the USA
Affected count
19,968 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0939-2023Don't want to check this manually?
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