Drug product
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
D-0494-2023
Product summary
- Event
- Event 91980
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 bottles
- Official record key
drug-enforcement:D-0494-2023
Official wording
Reason: cGMP Deviations
Code information: Lot #: B1789178-080122, Exp. Date 07/31/2023; B1675475-050522, Exp. Date 05/31/2023
Distribution pattern: RemedyRepack distributed product to consignees nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations