Drug product
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
D-0502-2023
Product summary
- Event
- Event 91980
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 76 bottles, b)151 bottles
- Official record key
drug-enforcement:D-0502-2023
Official wording
Reason: cGMP Deviations
Code information: Lot # a): B2038806-123022, B2014185-121422, B1925528-102522, Exp. Date 07/31/2025. Lot #: b): B2080829-012823, B1938007-110222, B2038746-123022, Exp. Date 07/31/2025.
Distribution pattern: RemedyRepack distributed product to consignees nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations