Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Finished product specification did not meet USP specifications.
Reason Subpotency: one product for active ingredient assay and another one for preservative assay
Reason GMP Deviations
Reason Lack of Processing Control
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
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