FDA recall D-1434-2014

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-05

Report date

2014-07-23

Termination date

2016-11-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1434-2014