Drug 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
D-1434-2014
Product summary
- Event
- Event 68481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,369 bottles
- Official record key
drug-enforcement:D-1434-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number