FDAFDA · Food and drugs·Recall number D-0290-2019
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
Published December 19, 2018 · Recall initiated: November 16, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP violations noted during the firm's most recent inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CAO Group, Inc.
- Distributor
- Nationwide in the US
- Lot
- Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.