Drug product
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
D-0754-2021
Product summary
- Event
- Event 88536
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
drug-enforcement:D-0754-2021
Official wording
Reason: A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Code information: Lot # B1273286-071521, Exp 07/31/2022
Distribution pattern: Product was distributed to two medical facilities in VA and FL.
Derived failure modes
-
Unknown
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.