AVKARE Inc. recalls Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-…
- Recall date
- June 9, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0631-2021
- FDA classification
- Class III
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- Distributed in Los Angeles California
Why it was recalled
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
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