BEUDAMED
    FDA Enforcement Class III Terminated

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    Recall: Z-2148-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2148-2016
    Event ID
    74030
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    GSK Consumer Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2016
    Initiation Date
    April 25, 2016
    Classification Date
    July 11, 2016
    Termination Date
    July 19, 2017
    Address
    184 Liberty Corner Rd Ste 200, Warren, NJ, 07059-6868, United States

    Description

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    Reason

    Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.

    Code Info

    Shipper case lot #8008580, Retal Carton Lot #4543U8008580

    Distribution

    US Nationwide

    Quantity

    1,440 cases ( 34, 560 retail - units )