Reported Jul 23, 2014 · Terminated
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also…
Axcentria Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Axcentria Pharmaceuticals, LLC · 306 Keystone Dr · Telford, PA · 18969
Is this the product you have?
- 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
- Lot codes and dates
- G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I13145 September 2015 J13165 October 2015 J13166 October 2015
- Amount recalled
- 20,369 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
This product could cause temporary or reversible health problems — stop using it.
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