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Dharma Research, Inc. recalls Dharma Cavity Varnish 15mL
Recalled December 3, 2014 · FDA recall Z-0476-2015 · Dharma Research
Hazard
During an FDA inspection it was found that the products are marketed without a cleared 510k. · FDA Class II
Units
916
Sold at
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.
Description
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Product
Dharma Cavity Varnish 15mL
Manufacturer(s)
Dharma Research, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →