FDA-Drug2017-08-23Class III

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

AVKARE Inc.
Hazard

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

Sold states
Nationwide
Affected count
1172 cartons (23440 tablets)
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1094-2017

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