FDAFDA · Food and drugs·Recall number Z-2069-2014
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.
Published July 23, 2014 · Recall initiated: June 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Axcentria Pharmaceuticals, LLC
- Distributor
- US distribution to NY and CA
- Lot
- lot # H13136, exp. August 2014.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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