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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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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
Distribution Pattern Nationwide, Great Britain, Mexico, Russia and The Ukraine.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #11L1074, Exp 07/14 Class II cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy 2491 Kits D-916-2013