Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA

Recall Number: D-1434-2014

Firm: Axcentria Pharmaceuticals, LLC

Classification: Class II

Status: Terminated

Report Date: 20140723

Initiation Date: 20140505

Termination Date: 20161128

Reason for Recall

Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number

Product Description

Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA