AVKARE Inc. recalls Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 3…
- Recall date
- July 19, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1094-2017
- FDA classification
- Class III
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed impurities/degradation specifications: Out of specification for a related compound C.
Class III means the product violates regulations but is not likely to cause harm.
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
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