Reported Feb 3, 2021 · Terminated

Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant…

Bausch Health Companies, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bausch Health Companies, Inc. · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867

Is this the product you have?

    • Phytonadione Tablets 5mg
    • 30-count bottle
    • Rx Only
  • Manufactured ForOceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
Lot codes and dates
  • Lot
    • 18L091P
    • Exp 05/2021
Amount recalled
14,089 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 11, 2022 · Data as of Sep 19, 5:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.