BEUDAMED
    FDA Recall Terminated

    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

    Recall: Z-0477-2016 · Initiated November 18, 2015

    Recall

    Recall Number
    Z-0477-2016
    Event Number
    72726
    Firm
    Rainbow Specialty & Health Products
    FEI Number
    3002654714
    Product Code
    GDY
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    November 18, 2015
    Terminated
    May 2, 2016
    Address
    3400 14th Ave, Unit # 28, Markham Canada

    Description

    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

    Reason

    Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

    Action

    Consignees have been made aware of the recall by FAX, e-mail and via telephone calls on 11/18/2015. Requested that distributors contact their clients, by telephone initially and then by email with written correspondence requesting them to recall the product from their clients.

    Distribution

    Nationwide. No foreign, govt/VA/military consignees.

    Quantity

    150