September 2013 FDA Recall Drug by Valeant Pharmaceuticals North Am
D-020-2014 - Labeling
This Class III drug recall was voluntarily initiated by Valeant Pharmaceuticals North Am on September 20, 2013 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in United States and the recall is currently terminated.
Recall Number: D-020-2014
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
09-20-2013
12-04-2013
45,000 tubes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Valeant Pharmaceuticals North Am
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States
03-24-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03
Batch or Lot Expiration Information
Lot# Lot AC27198F6
