Drug & medication recalls Moderate risk

CAO Group product recalled over manufacturing violations

Recall date
November 16, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
CAO Group, Inc. recalls fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Dis…
Recall number
D-0290-2019
FDA classification
Class II
Brand / firm
CAO Group, Inc.
Sold / distributed
Nationwide in the US

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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