Class II
Terminated
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
- Company
- Axcentria Pharmaceuticals Llc
- Recall Initiated
- May 5, 2014
- Posted
- July 23, 2014
- Recall Number
- D-1434-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,369 bottles
- Firm Location
- Telford, PA, United States
Reason for Recall
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Distribution
Nationwide
Lot / Code Info
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
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