D-0939-2023 Class II Terminated
FDA drug recall D-0939-2023 was initiated by Glenmark Therapeutics, Inc. on May 1, 2023 and is designated Class II. 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. The recall status is terminated (terminated September 17, 2024). Affected quantity: 19,968 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 26, 2023
- Initiation Date
- May 1, 2023
- Termination Date
- September 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,968 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
FA2022001B, Exp 03/2025