Oculus Recalls Ceramax Skin Barrier Cream Professional Samples
Oculus Innovative Sciences is recalling professional samples of Ceramax Skin Barrier Cream because they are not meeting stability standards.
The agency’s classification
FDA (Devices): 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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Oculus Innovative Sciences, Inc. is recalling professional samples of Ceramax Skin Barrier Cream. The recall involves 68,970 units of the 0.1 oz (3 g) professional sample size, specifically Lot 3045639 with an expiration date of 01/2018. These samples were distributed nationwide.
The firm initiated the recall after becoming aware that the professional samples are not meeting the stability standards set for the product. Ceramax is a topical skin care preparation intended to be used under the supervision of a health care professional to relieve and manage burning and itching associated with various dermatoses, including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions.
Health care professionals and consumers who have these professional samples should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with…
- Manufacturer
- Oculus Innovative Sciences, Inc.
- Hazard
- Affected units
- 68,970
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 (2)
- Lot 3045639
- expiration date: 01/2018
Distribution
Distributed nationwide across the United States.
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