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Recall Observatory FDA recall evidence

Drug 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.

D-1387-2020

June 29, 2020

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 86006
Status
Terminated
Classification
Class II
Quantity
498 tablets
Official record key
drug-enforcement:D-1387-2020

Official wording

Reason: FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.

Code information: Lot #: B0796217-020920, Exp. Date: 02/28/2021

Distribution pattern: Product was distributed to MN.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification