Bausch Health Companies, Inc. recalls Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant…
- Recall date
- January 7, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0244-2021
- FDA classification
- Class III
- Brand / firm
- Bausch Health Companies, Inc.
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
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