May 2014 FDA Recall Drug by Axcentria Pharmaceuticals, Llc
D-1434-2014 - Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number

This Class II drug recall was voluntarily initiated by Axcentria Pharmaceuticals, Llc on May 5, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product is being manufactured and distributed without a ndc number. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1434-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Initiated
05-05-2014
Reported
07-23-2014
Quantity
20,369 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68481
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Axcentria Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-28-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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