Oculus Innovative Sciences, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0763-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: November 21, 2016
Date Posted: December 21, 2016
Recall Number: Z-0763-2017
Event ID: 75770
Reason for Recall:

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

Status: Terminated
Product Quantity: 68,970 units
Code Information:

Lot 3045639, expiration date: 01/2018

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated