FDA Drug recall D-1434-2014
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA
- FDA Drug
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA by Axcentria Pharmaceuticals, citing marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1434-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-05 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Axcentria Pharmaceuticals |
| Distribution | US |
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
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Identifiers
| code_info | G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1434-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.