D-0290-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 19, 2018
- Initiation Date
- November 16, 2018
- Termination Date
- February 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 kits
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.
Distribution Pattern
Nationwide in the US
Code Information
Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020