BEUDAMED
    FDA Enforcement Class II Terminated

    Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

    Recall: Z-2053-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2053-2016
    Event ID
    73395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nephron Pharmaceuticals Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    November 16, 2015
    Classification Date
    June 27, 2016
    Termination Date
    January 9, 2017
    Address
    4121 SW 34th St, Orlando, FL, 32811-6475, United States

    Description

    Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

    Reason

    Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.

    Code Info

    Lot Number N4745A, Exp 09/16

    Distribution

    Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV and Internationally to Canada.

    Quantity

    11,208 cartons