BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0477-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0477-2016
    Event ID
    72726
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Rainbow Specialty & Health Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    November 18, 2015
    Classification Date
    December 23, 2015
    Termination Date
    May 2, 2016
    Address
    3400 14th Ave, Unit #28, N/A, Markham, N/A, N/A, 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.

    Code Info

    Lot - 5012, Exp-102016

    Distribution

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

    Quantity

    150