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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