Why it was recalled
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Product description
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
Lot numbers, UPCs & expiration codes
Lot #: B0796217-020920, Exp. Date: 02/28/2021
Where it was sold
Product was distributed to MN.
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-1387-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2020
- FDA report date
- Jul 22, 2020
- Quantity
- 498 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-1387-2020, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 86006
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: B0796217-020920, Exp. Date: 02/28/2021
- Postal code
- 15701-3571
- Report date
- Jul 22, 2020
- Product type
- Drugs
- Recall number
- D-1387-2020
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 498 tablets
- Termination date
- Sep 14, 2020
- Reason for recall
- FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
- Distribution pattern
- Product was distributed to MN.
- Recall initiation date
- Jun 29, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2020