Class II · Moderate risk
Voriconazole Tablets
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
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
Affected NDC
50268-0804-12
Compare with the code on your package — it is the most precise check available.
Drug: Voriconazole
- Recalling firm
- AVKARE Inc.
- NDC code
- 50268-804-12
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1094-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Voriconazole recalls
See all
Class II · Moderate risk
Voriconazole Tablets 50mg
CGMP Deviations
Class II · Moderate risk
Voriconazole Tablets 200 mg
CGMP Deviations
Class II · Moderate risk
Voriconazole Container Description: voriconazole The product…
CGMP Deviations
Class II · Moderate risk
Voriconazole for Oral Suspension
Labeling: Incorrect or Missing Package Insert
Other recalls by AVKARE Inc.
All 2017 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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