Home / Recalls / Dharma Research, Inc. / Z-0475-2015

Z-0475-2015 Class II Terminated

Recalled by Dharma Research, Inc. — Miami, FL

Recall Details

Product Type: Devices
Report Date: December 3, 2014
Initiation Date: September 29, 2014
Termination Date: October 3, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,842

Product Description

Dharma Cavity Varnish with Fluoride

Reason for Recall

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

Distribution Pattern

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.

Code Information

All Lots - Item #14-00015