Hemo-Stat Solution — Class II drug recall D-1434-2014
Terminated recall by Axcentria Pharmaceuticals, LLC, reported 2014-07-23, distributed nationwide. Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
| Recall number | D-1434-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Axcentria Pharmaceuticals, LLC, Telford, PA, United States |
| Recall initiated | 2014-05-05 |
| Classified | 2014-07-15 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2016-11-28 |
| Distributed | Nationwide (US) |
| Quantity | 20,369 bottles |
| Reason classes | unapproved product |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1434-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.