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 he…

Recall date

November 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0763-2017

FDA classification

Class II

Brand / firm

Oculus Innovative Sciences, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.