Ceramax Skin Barrier Cream: NET WT 0 — Class II medical device recall Z-0763-2017
Terminated recall by Oculus Innovative Sciences, Inc., reported 2016-12-21, distributed nationwide. Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product
| Recall number | Z-0763-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oculus Innovative Sciences, Inc., Petaluma, CA, United States |
| Recall initiated | 2016-11-21 |
| Classified | 2016-12-14 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2017-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 68,970 units |
| Reason classes | specification failure |
| Lot numbers | 3045639 |
| Expiration dates | 2018-01 |
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 various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.
Reason for recall
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0763-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.