Home / Recalls / Bausch Health Companies, Inc. / D-0244-2021

D-0244-2021 Class III Terminated

Recalled by Bausch Health Companies, Inc. — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
February 3, 2021
Initiation Date
January 7, 2021
Termination Date
February 11, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,089 bottles

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

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot: 18L091P, Exp 05/2021

Other recalls by Bausch Health Companies, Inc.

  • D-0355-2024 Class II — Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet (February 2, 2024)
  • D-0639-2021 Class III — Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceansid (June 8, 2021)
  • D-0638-2021 Class III — Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured f (June 8, 2021)
  • D-0243-2021 Class III — Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for (January 7, 2021)
  • D-0054-2021 Class II — Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oc (July 13, 2020)