Why it was recalled
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
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.
Lot numbers, UPCs & expiration codes
Lot #11L1074, NDC 62032-110; Expanded 8/29/2013 to include Lot 11J1075, NDC 62032-511, Exp. 10/14.
Where it was sold
Nationwide, Great Britain, Mexico, Russia and The Ukraine.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-916-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 1, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 2491 Kits; Expanded 8/29/2013 to include an additional 907 units.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medicis Pharmaceutical Corp
Original FDA data
Every field from FDA enforcement report D-916-2013, exactly as published.
Show all FDA fields
- City
- Scottsdale
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 65559
- Address
- 7720 N Dobson Rd
- Code information
- Lot #11L1074, NDC 62032-110; Expanded 8/29/2013 to include Lot 11J1075, NDC 62032-511, Exp. 10/14.
- Postal code
- 85256-2740
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-916-2013
- Classification
- Class II
- Recalling firm
- Medicis Pharmaceutical Corp
- Product quantity
- 2491 Kits; Expanded 8/29/2013 to include an additional 907 units.
- Termination date
- Apr 15, 2014
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide, Great Britain, Mexico, Russia and The Ukraine.
- Recall initiation date
- May 1, 2013
- Initial firm notification
- Telephone
- Center classification date
- Aug 22, 2013