May 2013 FDA Recall Drug by Medicis Pharmaceutical Corp
D-916-2013 - cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy

This Class II drug recall was voluntarily initiated by Medicis Pharmaceutical Corp on May 1, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations; during the production process, clenziderm m.d. daily foam cleanser was filled into some bottles labeled as clenziderm m.d. pore therapy. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-916-2013

Reason for Recall
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Initiated
05-01-2013
Reported
08-28-2013
Quantity
2491 Kits; Expanded 8/29/2013 to include an additional 907 units.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65559
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medicis Pharmaceutical Corp
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Great Britain, Mexico, Russia and The Ukraine.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-15-2014
Product Description About Product Description
Full technical description of the product.
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110.

Batch or Lot Expiration Information

Lot# 11L1074, NDC 62032-110; Expanded 8/29/2013 to include Lot 11J1075, NDC 62032-511, Exp. 10/14.