Voriconazole Tablet, Film Coated
FDA Recall NDC 60687-294
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Voriconazole (NDC 60687-294). A significant event, classified as Class II, was initiated on Mar 24, 2025 by American Health Packaging. The reported reason for this action was: "cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Mar 24, 2025
Apr 09, 2025
889 cartons
Recall Profile & Regulatory Data
Event ID
96574
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Feb 10, 2026
Product Description
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.
Batch or Lot Expiration Information
Lot# 1014138, Exp 04/30/2025
Affected Packages Involved in this Recall
60687-294-11Product
60687-294-21Product
60687-273-11Product
60687-273-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
