BEUDAMED
    FDA Recall Terminated

    Dharma Cavity Varnish 15mL

    Recall: Z-0476-2015 · Initiated September 29, 2014

    Recall

    Recall Number
    Z-0476-2015
    Event Number
    69386
    Firm
    Dharma Research, Inc.
    FEI Number
    3010131268
    Product Code
    LBH
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    September 29, 2014
    Posted
    December 1, 2014
    Terminated
    October 3, 2016
    Address
    5220 Nw 72nd Ave, Bay 15, Miami, FL, 33166-4860

    Description

    Dharma Cavity Varnish 15mL

    Reason

    During an FDA inspection it was found that the products are marketed without a cleared 510k.

    Action

    On September 29, 2014 the firm sent a notification to its consignees informing them of the product being discountued and removed. The firm asked for the product to be returned directly to Dharma's office at 5220 NW 72 Avenue, Suite 15, Miami FL 33166. For any questions please do not hesitate to call (305) 482-9669.

    Distribution

    Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates.

    Quantity

    916