Drug product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
D-0495-2023
Product summary
- Event
- Event 91980
- Status
- Terminated
- Classification
- Class II
- Quantity
- 399 bottles
- Official record key
drug-enforcement:D-0495-2023
Official wording
Reason: cGMP Deviations
Code information: Lot #: J0668398-121422, Exp. Date 12/31/2023; J0661225-111522, J0654053-101822 Exp. Date 11/30/2023; J0646383-091422, Exp. Date 09/30/2023
Distribution pattern: RemedyRepack distributed product to consignees nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations