Drug 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.
D-0939-2023
Product summary
- Event
- Event 92565
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,968 bottles
- Official record key
drug-enforcement:D-0939-2023
Official wording
Reason: 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.
Code information: FA2022001B, Exp 03/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Error