Drug Recall Enforcement Report Class II voluntary initiated by Amerisource Health Services LLC, originally initiated on 03-24-2025 for the 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. The product was recalled due to cgmp deviations: received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.. The product was distributed nationwide and the recall is currently ongoing.
| Field Name |
Field Value |
| Event ID |
96574 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-0307-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern |
USA nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| 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. |
| Reason For Recall |
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
889 cartons Product Quantity
The amount of product subject to recall. |
| Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date |
04-09-2025 |
| Recall Initiation Date |
03-24-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification |
Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type |
Drugs |
| Recalling Firm |
Amerisource Health Services LLC |
| Code Info |
Lot # 1014138, Exp 04/30/2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages |
60687-294-11; 60687-294-21; 60687-273-11; 60687-273-21 |
| Status |
Ongoing |
Recalled Products
