Status
Terminated
Drug Enforcement D-916-2013
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Classification
Class II
Report Date
August 28, 2013
Termination Date
April 15, 2014
Product Information
- 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.
- Product quantity
- 2491 Kits; Expanded 8/29/2013 to include an additional 907 units.
- 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
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide, Great Britain, Mexico, Russia and The Ukraine.
Location & Firm
- Recalling firm
- Medicis Pharmaceutical Corp
- Address
-
7720 N Dobson Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-916-2013
- Event ID
- 65559
- Recall initiation date
- May 1, 2013
- Center classification date
- August 22, 2013
- Code info
- Lot #11L1074, NDC 62032-110; Expanded 8/29/2013 to include Lot 11J1075, NDC 62032-511, Exp. 10/14.
- More code info
- —