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Recall Enforment Report D-0639-2021

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Bausch Health Companies, Inc., originally initiated on 06-08-2021 for the product Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30 The product was recalled due to failed impurities/degradation specifications. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0639-202106-08-202106-30-2021Class III37,797 bottlesPhytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30Failed Impurities/Degradation SpecificationsTerminated
D-0638-202106-08-202106-30-2021Class III2,691 bottlesMephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.Failed Impurities/Degradation SpecificationsTerminated