BEUDAMED
    FDA Enforcement Class II Ongoing

    WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)

    Recall: Z-1499-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1499-2023
    Event ID
    91970
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ASO LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 10, 2023
    Initiation Date
    March 23, 2023
    Classification Date
    May 2, 2023
    Address
    300 Sarasota Center Blvd, Sarasota, FL, 34240-9381, United States

    Description

    WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)

    Reason

    The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.

    Code Info

    UDI/DI 311917124506; Lot Numbers: 00176259, 00176260, 00176582.

    Distribution

    US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI

    Quantity

    919 cases of 24 units