Drug Enforcement D-0307-2025

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

Status

Ongoing

Classification

Class II

Report Date

April 9, 2025

Termination Date

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Product Information

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.
Product quantity
889 cartons
Reason for recall
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0307-2025
Event ID
96574
Recall initiation date
March 24, 2025
Center classification date
March 28, 2025
Code info
Lot # 1014138, Exp 04/30/2025
More code info
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