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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard involves failed specifications for impurities and degradation—a quality/manufacturing issue without evidence of direct patient harm, placing it in the Low category per the rubric.
Plain-English summary
Bausch Health Companies, Inc. is recalling Phytonadione Tablets, 5 mg (NDC 68682-170-30), manufactured for Oceanside Pharmaceuticals. The recall affects 37,797 bottles distributed nationwide due to failed impurities and degradation specifications.
The affected lots are: Lot #19D013P (Expiration 07/2021) and Lot #20D099P (Expiration 10/2022).
Phytonadione is a prescription medication used to treat vitamin K deficiency and certain bleeding disorders. Patients currently taking this medication should contact their healthcare provider to discuss their treatment options and determine whether to continue use or request an alternative supply.
The recalled product
- 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
- Manufacturer
- Bausch Health Companies, Inc.
- Category
- Drug — Tablet / Oral
- Affected units
- 37,797
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #:19D013P
- Exp Date 07/2021
- 20D099P
- Exp Date 10/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bausch Health Companies, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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