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.
Reported: July 22, 2020 Initiated: June 29, 2020 #D-1387-2020
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.
Reason for Recall
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 498 tablets
- Distribution
- Product was distributed to MN.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by RemedyRepack Inc.. Units affected: 498 tablets.
Why was this product recalled? ▼
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 22, 2020. Severity: Moderate. Recall number: D-1387-2020.
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