RecallDepth
Class II Terminated

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.

This recall has been terminated (originally issued August 28, 2013).

Company
Medicis Pharmaceutical Corp
Recall Initiated
May 1, 2013
Posted
August 28, 2013
Recall Number
D-916-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
2491 Kits; Expanded 8/29/2013 to include an additional 907 units.
Firm Location
Scottsdale, AZ, United States
Official Source
View on FDA website ↗

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

Distribution

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

Lot / Code Info

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

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