October 2014 FDA Recall Obagi Nu-derm System Normal-oily Skin Transformation by Obagi Medical Products
D-0234-2015 - Labeling

This Class II drug recall was voluntarily initiated by Obagi Medical Products on October 17, 2014 for the product Obagi Nu-derm System Normal-oily Skin Transformation. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0234-2015

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.
Initiated
10-17-2014
Reported
11-12-2014
Quantity
975 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69569
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Obagi Medical Products
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Mexico and Slovenia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-29-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 13I1218, Product/Part #: 362032101361, Exp 09/30/2016

Affected Packages Involved in this Recall

62032-912-01 Obagi Nu-derm System Normal-oily Skin Transformation