Recalls / Class II
Class IID-0939-2023
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.
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Oral
- NDCs
- 72657-112, 72657-113, 72657-132
- FDA application
- ANDA215822
- Affected lot / code info
- FA2022001B, Exp 03/2025
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.
Recalling firm
- Firm
- Glenmark Therapeutics, Inc.
- Manufacturer
- GLENMARK THERAPEUTICS INC., USA
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 19,968 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-05-01
- FDA classified
- 2023-07-21
- Posted by FDA
- 2023-07-26
- Terminated
- 2024-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0939-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.