Home / Recalls / Axcentria Pharmaceuticals, LLC / D-1434-2014

D-1434-2014 Class II Terminated

Recalled by Axcentria Pharmaceuticals, LLC — Telford, PA

Recall Details

Product Type
Drugs
Report Date
July 23, 2014
Initiation Date
May 5, 2014
Termination Date
November 28, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,369 bottles

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

Distribution Pattern

Nationwide

Code Information

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

Other recalls by Axcentria Pharmaceuticals, LLC

  • Z-2069-2014 Class II — Calcium Hydroxide Powder, USP For use in root canal therapy by health care pr (June 5, 2014)
  • D-134-2013 Class III — Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: M (August 17, 2012)
  • D-1441-2012 Class III — Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) (July 12, 2012)