Bausch Health Companies, Inc.: Drug Recall

Recall #D-0244-2021 · 01/07/2021

Class III: Low Risk

Recall Details

Recall Number
D-0244-2021
Classification
Class III
Product Type
Drug
Recalling Firm
Bausch Health Companies, Inc.
Status
Terminated
Date Initiated
01/07/2021
Location
Bridgewater, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,089 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Distributed Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.