Class II · Moderate risk Terminated
Voriconazole Tablets
Reason cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Voriconazole Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed impurities/degradation specifications: Out of specification for a related compound C.
What was recalled
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
- Recalling firm
- AVKARE Inc.
- NDC code
- 50268-804-12
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1094-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Voriconazole recalls
See all
Class II · Moderate risk Ongoing
Voriconazole Tablets 50mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Voriconazole Tablets 200 mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Voriconazole Container Description: voriconazole The product…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Voriconazole for Oral Suspension
Reason Labeling: Incorrect or Missing Package Insert
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