FDA recall D-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.

Reason for recall

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2025-03-24

Report date

2025-04-09

Termination date

2026-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0307-2025