BEUDAMED
    FDA Enforcement Class II Terminated

    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

    Recall: Z-1699-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1699-2016
    Event ID
    73678
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Valeant Pharmacueticals International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2016
    Initiation Date
    January 29, 2016
    Classification Date
    May 19, 2016
    Termination Date
    October 6, 2017
    Address
    400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, 08807-2867, United States

    Description

    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

    Reason

    It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.

    Code Info

    Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757

    Distribution

    Nationwide Distribution

    Quantity

    7,716