Product: fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Reason for recall: cGMP violations noted during the firm's most recent inspection.
Recall initiated: 20181116
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated