BEUDAMED
    FDA Recall Terminated

    DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.

    Recall: Z-0239-04 · Initiated March 20, 2003

    Recall

    Recall Number
    Z-0239-04
    Event Number
    27817
    Firm
    Drug Free Enterprises Inc
    FEI Number
    3003470018
    Product Code
    DIO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2003
    Posted
    December 18, 2003
    Terminated
    December 17, 2003
    Address
    5302 Derry Ave, Ste A, Agoura Hills, CA, 91301-6022

    Description

    DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.

    Reason

    Lacks professional use labeling and firm name and address.

    Action

    Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.

    Distribution

    Nationwide.

    Quantity

    2800 units