Why it was recalled
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Product description
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Lot numbers, UPCs & expiration codes
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
Where it was sold
FL
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-0217-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 24, 2025
- FDA report date
- Feb 12, 2025
- Quantity
- 247 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0217-2025, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 96191
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
- Postal code
- 15701-3571
- Report date
- Feb 12, 2025
- Product type
- Drugs
- Recall number
- D-0217-2025
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 247 blister packs
- Termination date
- Jul 17, 2025
- Reason for recall
- CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
- Distribution pattern
- FL
- Recall initiation date
- Jan 24, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 3, 2025