D-0234-2015 Class II Terminated
FDA drug recall D-0234-2015 was initiated by Obagi Medical Products on October 17, 2014 and is designated Class II. Reason for recall: Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX… The recall status is terminated (terminated April 29, 2015). Affected quantity: 975 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 12, 2014
- Initiation Date
- October 17, 2014
- Termination Date
- April 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 975 bottles
Product Description
Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36
Reason for Recall
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Distribution Pattern
Nationwide and Mexico and Slovenia
Code Information
Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016