Carbamazepine 200 mg Tablets recall: Failed Dissolution
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…
Why was Carbamazepine 200 mg Tablets recalled?
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: B0796217-020920, Exp. Date: 02/28/2021
- 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…
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 498 tablets
- Distribution
- Product was distributed to MN.
- Recall date
- July 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)