BEUDAMED
    FDA Recall 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 · Initiated November 16, 2015

    Recall

    Recall Number
    Z-2053-2016
    Event Number
    73395
    Firm
    Nephron Pharmaceuticals Corp.
    FEI Number
    3010892830
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 16, 2015
    Posted
    June 27, 2016
    Terminated
    January 9, 2017
    Address
    4121 SW 34th St, Orlando, FL, 32811-6475

    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.

    Action

    Nephron Pharmaceuticals Corporation sent an Urgent Drug Recall letter to all affected customers on November 16, 2015. The letter identified the product, the problem, and the action to be taken by the customer. NPC requested customers remove the affected lots from their inventory, including store shelves. Customers with questions should call 1-844-374-6841

    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