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
D-0290-2019
Product summary
- Firm
- CAO Group, Inc.
- Event
- Event 81556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115 kits
- Official record key
drug-enforcement:D-0290-2019
Official wording
Reason: cGMP violations noted during the firm's most recent inspection.
Code information: Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
cGMP violations