FDAFDA · Food and drugs·Recall number D-1387-2020
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.
Published July 22, 2020 · Recall initiated: June 29, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Product was distributed to MN.
- Lot
- Lot #: B0796217-020920, Exp. Date: 02/28/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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