Recalls / Class III
Class IIID-0998-2017
Product
Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
- Affected lot / code info
- Lot #: 2578400, 0Exp 8/2019
Why it was recalled
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
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
- 844 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2017-06-28
- FDA classified
- 2017-07-14
- Posted by FDA
- 2017-07-26
- Terminated
- 2018-01-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0998-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.