Recalls / Class II
Class IID-1387-2020
Product
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.
- Affected lot / code info
- Lot #: B0796217-020920, Exp. Date: 02/28/2021
Why it was recalled
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 498 tablets
- Distribution pattern
- Product was distributed to MN.
Timeline
- Recall initiated
- 2020-06-29
- FDA classified
- 2020-07-14
- Posted by FDA
- 2020-07-22
- Terminated
- 2020-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1387-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.