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Recall Observatory FDA recall evidence

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

D-0998-2017

June 28, 2017

Class III

Product summary

Firm
Valeant Pharmaceuticals North America LLC
Event
Event 77659
Status
Terminated
Classification
Class III
Quantity
844 bottles
Official record key
drug-enforcement:D-0998-2017

Official wording

Reason: 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.

Code information: Lot #: 2578400, 0Exp 8/2019

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing