Glenmark Therapeutics, Inc.: Drug Recall
Recall #D-0939-2023 · 05/01/2023
Class II: Risk
Recall Details
- Recall Number
- D-0939-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Glenmark Therapeutics, Inc.
- Status
- Terminated
- Date Initiated
- 05/01/2023
- Location
- Mahwah, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,968 bottles
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.
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.
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.