Multi-event March 2017 FDA Recall Drug by Valeant Pharmaceuticals North America Llc

This Multi-event Class III drug recall was voluntarily initiated by Valeant Pharmaceuticals North America Llc on March 20, 2017 for the product Drug. The FDA reported the reason for recall as discoloration.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0672-2017 TERMINATED D-0673-2017 TERMINATED

Recall Number: D-0672-2017

Reason for Recall
Discoloration.
Initiated
03-20-2017
Reported
04-26-2017
Quantity
38,767 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76743
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.
Valeant Pharmaceuticals North America LLC
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.
nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2019
Product Description About Product Description
Full technical description of the product.
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04

Batch or Lot Expiration Information

Lot# : 15J1277, Exp. 04/2017

Recall Number: D-0673-2017

Reason for Recall
Discoloration.
Initiated
03-20-2017
Reported
04-26-2017
Quantity
5,647 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76743
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.
Valeant Pharmaceuticals North America LLC
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.
nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2019
Product Description About Product Description
Full technical description of the product.
CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01

Batch or Lot Expiration Information

Lot# : a) 15I1234, Exp. 09/18, b) 15E1221, Exp. 09/18, c) 15G1235 and 15I1236, Exp. 09/18.