Recalls / Class II
Class IID-0307-2025
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.
- Brand name
- Voriconazole
- Generic name
- Voriconazole
- Active ingredient
- Voriconazole
- Route
- Oral
- NDCs
- 60687-273, 60687-294
- FDA application
- ANDA203503
- Affected lot / code info
- Lot # 1014138, Exp 04/30/2025
Why it was recalled
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 889 cartons
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2025-03-24
- FDA classified
- 2025-03-28
- Posted by FDA
- 2025-04-09
- Terminated
- 2026-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0307-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.