Drug product
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.
D-916-2013
Product summary
- Event
- Event 65559
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2491 Kits; Expanded 8/29/2013 to include an additional 907 units.
- Official record key
drug-enforcement:D-916-2013
Official wording
Reason: cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Code information: Lot #11L1074, NDC 62032-110; Expanded 8/29/2013 to include Lot 11J1075, NDC 62032-511, Exp. 10/14.
Distribution pattern: Nationwide, Great Britain, Mexico, Russia and The Ukraine.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations