BEUDAMED
    FDA Enforcement Class II Terminated

    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth

    Recall: Z-0272-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0272-2014
    Event ID
    66689
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GlaxoSmithKline, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    October 17, 2013
    Classification Date
    November 13, 2013
    Termination Date
    July 26, 2017
    Address
    1011 North Arendell Ave, Zebulon, NC, 27597-1217, United States

    Description

    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth

    Reason

    Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

    Code Info

    UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.

    Distribution

    Nationwide Distribution .

    Quantity

    483,204 bottles