FDAFDA · Food and drugs·Recall number D-0244-2021
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
Published February 3, 2021 · Recall initiated: January 7, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bausch Health Companies, Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot: 18L091P, Exp 05/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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