BEUDAMED
    FDA Recall Terminated

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    Recall: Z-2476-2015 · Initiated July 2, 2015

    Recall

    Recall Number
    Z-2476-2015
    Event Number
    71735
    Firm
    MRP, LLC dba AMUSA
    FEI Number
    1000151124
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 2, 2015
    Posted
    August 27, 2015
    Terminated
    April 3, 2017
    Address
    5209 Linbar Dr, Ste 640, Nashville, TN, 37211-1026

    Description

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    Reason

    Procedures for the acceptance and control of in-process product have not been adequately established.

    Action

    The firm notified their consignees of the recall by Fed Ex on 07/02/2015. The firm requested the return of the product. Distributors were instructed to notify their customers.

    Distribution

    Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.

    Quantity

    551 cases