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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description 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.
Recall Number D-916-2013
Classification Class II
Code Info Lot #11L1074, Exp 07/14
Product Distributed Qty 2491 Kits
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

Event Detail

Event Id 65559
Product Type Drugs
Status Ongoing
Recalling Firm Medicis Pharmaceutical Corp
City Scottsdale
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-01
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide, Great Britain, Mexico, Russia and The Ukraine.