BEUDAMED
    FDA Enforcement Class III Terminated

    iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

    Recall: Z-0454-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0454-2022
    Event ID
    89161
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tapemark Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 12, 2022
    Initiation Date
    November 10, 2021
    Classification Date
    January 5, 2022
    Termination Date
    February 1, 2023
    Address
    1685 Marthaler Ln, N/A, Saint Paul, MN, 55118-3517, United States

    Description

    iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

    Reason

    The dosage information on the pouch is incorrect; the primary carton label is correct.

    Code Info

    Lot numbers 1131-1 and 1131-2

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.

    Quantity

    5,141 primary cartons