fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes...
FDA Recall #D-0290-2019 — Class II — November 16, 2018
Product Description
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.
Recalling Firm
CAO Group, Inc. — West Jordan, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
115 kits
Distribution
Nationwide in the US
Code Information
Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated