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
Reported: February 3, 2021 Initiated: January 7, 2021 #D-0244-2021
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Details
- Recalling Firm
- Bausch Health Companies, Inc.
- Units Affected
- 14,089 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product 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. Recalled by Bausch Health Companies, Inc.. Units affected: 14,089 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 3, 2021. Severity: Low. Recall number: D-0244-2021.
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