Recalls / Class III
Class IIID-0673-2017
Product
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
- Affected lot / code info
- Lot #: a) 15I1234, Exp. 09/18, b) 15E1221, Exp. 09/18, c) 15G1235 and 15I1236, Exp. 09/18.
Why it was recalled
Discoloration.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 5,647 units
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2017-03-20
- FDA classified
- 2017-04-17
- Posted by FDA
- 2017-04-26
- Terminated
- 2019-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0673-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.