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.
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.
Lot numbers, UPCs & expiration codes
FA2022001B, Exp 03/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0939-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 1, 2023
- FDA report date
- Jul 26, 2023
- Quantity
- 19,968 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Therapeutics, Inc.
Original FDA data
Every field from FDA enforcement report D-0939-2023, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92565
- Address
- 750 Corporate Dr
- Code information
- FA2022001B, Exp 03/2025
- Postal code
- 07430-2009
- Report date
- Jul 26, 2023
- Product type
- Drugs
- Recall number
- D-0939-2023
- Classification
- Class II
- Recalling firm
- Glenmark Therapeutics, Inc.
- Product quantity
- 19,968 bottles
- Termination date
- Sep 17, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- May 1, 2023
- Center classification date
- Jul 21, 2023