D-916-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2013
- Initiation Date
- May 1, 2013
- Termination Date
- April 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2491 Kits; Expanded 8/29/2013 to include an additional 907 units.
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.
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 Pattern
Nationwide, Great Britain, Mexico, Russia and The Ukraine.
Code Information
Lot #11L1074, NDC 62032-110; Expanded 8/29/2013 to include Lot 11J1075, NDC 62032-511, Exp. 10/14.