Why it was recalled
Discoloration.
Product description
CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01
Lot numbers, UPCs & expiration codes
Lot #: a) 15I1234, Exp. 09/18, b) 15E1221, Exp. 09/18, c) 15G1235 and 15I1236, Exp. 09/18.
Where it was sold
nationwide
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-0673-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 20, 2017
- FDA report date
- Apr 26, 2017
- Quantity
- 5,647 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0673-2017, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76743
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: a) 15I1234, Exp. 09/18, b) 15E1221, Exp. 09/18, c) 15G1235 and 15I1236, Exp. 09/18.
- Postal code
- 08807-2867
- Report date
- Apr 26, 2017
- Product type
- Drugs
- Recall number
- D-0673-2017
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 5,647 units
- Termination date
- Jun 14, 2019
- Reason for recall
- Discoloration.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01
- Distribution pattern
- nationwide
- Recall initiation date
- Mar 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 17, 2017