FDA recall D-916-2013

Medicis Pharmaceutical Corp · Class II · 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.

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.

Key facts

Status: Terminated
Initiation date: 2013-05-01
Report date: 2013-08-28
Termination date: 2014-04-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Scottsdale, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-916-2013