FDA recall D-0290-2019

CAO Group, Inc. · Class II · drug

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.

Distribution

Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2018-11-16
Report date: 2018-12-19
Termination date: 2020-02-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: West Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2019