FDA-Drug2018-12-19Class II
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
CAO Group, Inc.
Hazard
cGMP violations noted during the firm's most recent inspection.
Sold states
Nationwide in the US
Affected count
115 kits
Manufactured in
4628 W Skyhawk Dr, N/A, West Jordan, UT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2019Don't want to check this manually?
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