Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval
Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.
- 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 de
- Category
- Medical Device
- Distribution
- 2 states