RecallWatchUSA

Home / Recalls / Medical Devices

Oculus Innovative Sciences, Inc. recalls Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a

Recalled December 21, 2016 · FDA recall Z-0763-2017 · Oculus Innovative Sciences

Hazard
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product. · FDA Class II
Units
68,970 units
Sold at
Nationwide Distribution

Description

Firm became aware that professional samples of Ceramax are not meeting stability standards set for the 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 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.
Manufacturer(s)
Oculus Innovative Sciences, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Oculus Innovative Sciences, Inc. recalls Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a | RecallWatchUSA