FDA recall D-0998-2017

Valeant Pharmaceuticals North America LLC · Class III · drug

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

Reason for recall

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.

Distribution

U.S. Nationwide

Key facts

Status
Terminated
Initiation date
2017-06-28
Report date
2017-07-26
Termination date
2018-01-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0998-2017