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Recall Observatory FDA recall evidence

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

October 17, 2014

Class II

Product summary

Firm
Obagi Medical Products
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

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up