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.

Hemo-Stat Solution Recalled by Axcentria Pharmaceuticals, LLC Due to Marketed without an Approved NDA/ANDA; product is being...

Date: May 5, 2014
Company: Axcentria Pharmaceuticals, LLC
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 Axcentria Pharmaceuticals, LLC directly.

Affected Products

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

Quantity: 20,369 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Axcentria Pharmaceuticals, LLC

Axcentria Pharmaceuticals, LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

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