FDA Device recall Z-0763-2017
Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care profession…
- FDA Device
- Class II
- terminated
- Published 2016-12-21
On 2016-12-21 the FDA classified a Class II recall of Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care profession… by Oculus Innovative Sciences, citing firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0763-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-21 |
| Published | 2016-12-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Oculus Innovative Sciences |
| Distribution | US |
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
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Identifiers
| code_info | Lot 3045639, expiration date: 01/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0763-2017%22
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