BEUDAMED
    FDA Recall Terminated

    Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole

    Recall: Z-0371-2016 · Initiated September 14, 2015

    Recall

    Recall Number
    Z-0371-2016
    Event Number
    72198
    Firm
    Valeant Pharmaceuticals North America LLC
    FEI Number
    3010446985
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 14, 2015
    Posted
    December 4, 2015
    Terminated
    June 27, 2017
    Address
    400 Somerset Corporate Blvd, Bridgewater, NJ, 08807-2867

    Description

    Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole

    Reason

    SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

    Action

    Valeant Pharmaceuticals International issued recall letter/return response form dated 9/11/2015 via 2nd day air service Customers were requested to check their inventory for the SPAG-2 device and sgregate it for return shipment.

    Distribution

    AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX

    Quantity

    61 units