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
Recall initiated: 20140505
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated