Drug product
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
D-0234-2015
Product summary
- Event
- Event 69569
- Status
- Terminated
- Classification
- Class II
- Quantity
- 975 bottles
- Official record key
drug-enforcement:D-0234-2015
Official wording
Reason: 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.
Code information: Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016
Distribution pattern: Nationwide and Mexico and Slovenia
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up