The Recall Desk

FDA (Drugs) recall action 88079

Bausch Health Companies, Inc. recalled 2 products on 2021-06-30

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-06-30
Critical
0
Units
40,488

Why these products were recalled

Failed Impurities/Degradation Specifications

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2021-06-30

    Mephyton Phytonadione 5 mg Tablets Recall for Failed Impurity Specifications

    Bausch Health Companies is recalling Mephyton (Phytonadione) 5 mg tablets nationwide because certain lots failed impurities and degradation specifications. Affected consumers should contact their healthcare provider.

    Product
    Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2021-06-30

    Phytonadione 5 mg Tablets Recalled for Failed Impurity Specifications

    Bausch Health Companies is recalling Phytonadione 5 mg tablets distributed nationwide because the affected lots failed to meet impurity and degradation specifications. Consumers should consult their healthcare provider before stopping this medication.

    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
    Category
    Distribution
    0 states