Drug product
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
D-0307-2025
Product summary
- Event
- Event 96574
- Status
- Terminated
- Classification
- Class II
- Quantity
- 889 cartons
- Official record key
drug-enforcement:D-0307-2025
Official wording
Reason: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Code information: Lot # 1014138, Exp 04/30/2025
Distribution pattern: USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations