FDAClass IIIFebruary 3, 2021

Phytonadione Tablets 5mg recall: Impurity Out of Spec

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

Why was Phytonadione Tablets 5mg recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 18L091P, Exp 05/2021

Product
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America…
Recalling firm
Bausch Health Companies, Inc.
Quantity
14,089 bottles
Distribution
Distributed Nationwide in the USA
Recall date
February 3, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls