Obagi Nu-derm System Normal-oily Skin Transformation Kit
FDA Recall NDC 62032-912
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Obagi Nu-derm System Normal-oily Skin Transformation (NDC 62032-912). A significant event, classified as Class II, was initiated on Oct 17, 2014 by Obagi Cosmeceuticals Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Oct 17, 2014
Nov 12, 2014
975 bottles
Recall Profile & Regulatory Data
Event ID
69569
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Obagi Medical Products
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Mexico and Slovenia
Termination Date
Apr 29, 2015
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
Batch or Lot Expiration Information
Lot# : 13I1218, Product/Part #: 362032101361, Exp 09/30/2016
Affected Packages Involved in this Recall
62032-912-01Product
62032-101-36Product
62032-100-36Product
62032-140-09Product
3620321013Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
