Multi-event January 2021 FDA Recall Drug by Bausch Health Companies, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Bausch Health Companies, Inc. on January 7, 2021 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0243-2021 TERMINATED D-0244-2021 TERMINATED

Recall Number: D-0243-2021

Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Initiated
01-07-2021
Reported
02-03-2021
Quantity
895 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87093
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bausch Health Companies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-11-2022
Product Description About Product Description
Full technical description of the product.
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

Batch or Lot Expiration Information

Lot# Lot: 18L092P, Exp 05/2021

Recall Number: D-0244-2021

Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Initiated
01-07-2021
Reported
02-03-2021
Quantity
14,089 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87093
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bausch Health Companies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-11-2022
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot: 18L091P, Exp 05/2021