Obagi Nu-Derm Clear Prescription Cream Recalled for Labeling Error
Obagi Medical Products is recalling 975 bottles of Obagi Nu-Derm Clear due to a labeling mix-up where Exfoderm Forte contents were shipped.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mix-up where the wrong product was shipped. This aligns with the rubric criterion for minor labeling errors or low-risk contamination.
Plain-English summary
Obagi Medical Products is recalling 975 bottles of Obagi Nu-Derm Clear, a prescription skin treatment containing hydroquinone, homosalate, octisalate, and zinc oxide. The recall involves Lot # 13I1218, which expires on 09/30/2016. The product was distributed nationwide as well as in Mexico and Slovenia.
The recall was initiated due to a labeling error where pre-labeled bottles of Obagi Nu-Derm Clear were inadvertently introduced into the Obagi Exfoderm Forte packaging line. As a result, customers who ordered Obagi Nu-Derm Clear received bottles containing Obagi Exfoderm Forte instead.
Consumers who purchased this specific lot should stop using the product and contact their healthcare provider or the recalling firm for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION (HYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDE)
- Brand
- OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION
- Manufacturer
- Obagi Medical Products
- Category
- Drug — Topical Prescription
- Hazard
- Affected units
- 975
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 13I1218
- Product/Part #: 362032101361
- Exp 09/30/2016
UPCs (1)
- 362032101361
Distribution
Distributed nationwide across the United States.
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