Drug product
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
D-0497-2023
Product summary
- Event
- Event 91980
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 bottles
- Official record key
drug-enforcement:D-0497-2023
Official wording
Reason: cGMP Deviations
Code information: Lot #: B1635780-040522, Exp. Date 04/30/2023
Distribution pattern: RemedyRepack distributed product to consignees nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations