Recalls / Class II
Class IID-0234-2015
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
- Brand name
- Obagi Nu-derm System Normal-oily Skin Transformation
- Generic name
- Hydroquinone, Homosalate, Octisalate, Zinc Oxide
- NDC
- 62032-912
- Affected lot / code info
- Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016
Why it was recalled
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.
Recalling firm
- Firm
- Obagi Medical Products
- Manufacturer
- Obagi Cosmeceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Technology Dr, N/A, Irvine, California 92618-2301
Distribution
- Quantity
- 975 bottles
- Distribution pattern
- Nationwide and Mexico and Slovenia
Timeline
- Recall initiated
- 2014-10-17
- FDA classified
- 2014-10-31
- Posted by FDA
- 2014-11-12
- Terminated
- 2015-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0234-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.