PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: August 23, 2017 Initiated: July 19, 2017 #D-1094-2017

Product Description

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

Reason for Recall

Failed impurities/degradation specifications: Out of specification for a related compound C.

Details

Recalling Firm
AVKARE Inc.
Units Affected
1172 cartons (23440 tablets)
Distribution
Nationwide
Location
Pulaski, TN

Frequently Asked Questions

What product 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. Recalled by AVKARE Inc.. Units affected: 1172 cartons (23440 tablets).
Why was this product recalled?
Failed impurities/degradation specifications: Out of specification for a related compound C.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 23, 2017. Severity: Low. Recall number: D-1094-2017.