Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

fas.TRACT Coagulative Hemostatic Gel Recalled by CAO Group, Inc. Due to cGMP violations noted during the firm's most recent...

Date: November 16, 2018
Company: CAO Group, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CAO Group, Inc. directly.

Affected 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

Quantity: 115 kits

Why Was This Recalled?

cGMP violations noted during the firm's most recent inspection.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CAO Group, Inc.

CAO Group, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report