Recall Z-2069-2014— Axcentria Pharmaceuticals, LLC
Class II · Terminated
Class II FDA medical device recall by Axcentria Pharmaceuticals, LLC, initiated 2014-06-05, terminated 2016-11-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Axcentria Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-05
- Terminated
- 2016-11-28
- Firm location
- Telford, PA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.