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
Reported: July 23, 2014 Initiated: May 5, 2014 #D-1434-2014
Product Description
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
Details
- Recalling Firm
- Axcentria Pharmaceuticals, LLC
- Units Affected
- 20,369 bottles
- Distribution
- Nationwide
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Axcentria Pharmaceuticals, LLC. Units affected: 20,369 bottles.
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2014. Severity: Moderate. Recall number: D-1434-2014.
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