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Axcentria Pharmaceuticals, LLC recalls Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage
Recalled July 23, 2014 · FDA recall Z-2069-2014 · Axcentria Pharmaceuticals
Hazard
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use. · FDA Class II
Units
528
Sold at
US distribution to NY and CA
Description
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Product
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
Manufacturer(s)
Axcentria Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →