BEUDAMED
    FDA Recall Terminated

    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

    Recall: Z-1372-2013 · Initiated April 30, 2013

    Recall

    Recall Number
    Z-1372-2013
    Event Number
    65070
    Firm
    Nephron Pharmaceuticals Corp.
    FEI Number
    3010892830
    Product Code
    CCQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 30, 2013
    Posted
    May 29, 2013
    Terminated
    June 28, 2016
    Address
    4121 SW 34th St, Orlando, FL, 32811-6475

    Description

    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

    Reason

    Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

    Action

    The firm, Nephron Pharmaceuticals Corporation, notified its consignees on April 30, 2013, and May 3, 2013, of the problem via a recall notice and a Press Release, respectively. The firm directed consignees to discontinue use of any EZ Breathe atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers and also those that were sold individually. Customers were directed to return all affected product.

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.

    Quantity

    241,538 kits