BEUDAMED
    FDA Enforcement Class II Terminated

    SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

    Recall: Z-1182-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1182-2021
    Event ID
    87371
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunstar Americas, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 17, 2021
    Initiation Date
    February 18, 2021
    Classification Date
    March 5, 2021
    Termination Date
    September 30, 2024
    Address
    301 E Central Rd, Schaumburg, IL, 60195-1901, United States

    Description

    SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

    Reason

    The product may be contaminated with Burkholderia cepacia

    Code Info

    All lot codes within expiry

    Distribution

    US Nationwide distribution.

    Quantity

    56960 bottles