RemedyRepack Inc. recalls Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 1570

Recalled July 22, 2020 · FDA recall D-1387-2020 · RemedyRepack

Hazard

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

Units

498 tablets

Sold at

Product was distributed to MN.

Description

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

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.

Manufacturer(s)

RemedyRepack Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →