BEUDAMED
    FDA Recall 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 · Initiated November 21, 2016

    Recall

    Recall Number
    Z-0763-2017
    Event Number
    75770
    Firm
    Oculus Innovative Sciences, Inc.
    FEI Number
    3004554409
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 21, 2016
    Posted
    December 14, 2016
    Terminated
    June 13, 2017
    Address
    1129 N McDowell Blvd, Petaluma, CA, 94954-1110

    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.

    Action

    Oculus issued Medical Device Recall letters dated November 21, 2016, to Sales reps notifying them to stop all further distribution and immediately remove the affected lots of Recall product from sample inventory. Customers were also instructed to sign the Response form verifying receipt of the letter. Customers with questions were instructed to call Oculus Innovative Science-Regulatory Affairs at 707-559-7181. For questions regarding this recall call 559-7191.

    Distribution

    Nationwide Distribution

    Quantity

    68,970 units