Recalls / Class III
Class IIID-0672-2017
Product
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
- Affected lot / code info
- Lot #: 15J1277, Exp. 04/2017
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
- 38,767 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-0672-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.