BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0763-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0763-2017
    Event ID
    75770
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oculus Innovative Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 21, 2016
    Classification Date
    December 14, 2016
    Termination Date
    June 13, 2017
    Address
    1129 N McDowell Blvd, Petaluma, CA, 94954-1110, United States

    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.

    Reason

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

    Code Info

    Lot 3045639, expiration date: 01/2018

    Distribution

    Nationwide Distribution

    Quantity

    68,970 units