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American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
Date:6/15/2011

SHIRLEY, N.Y., June 15, 2011 /PRNewswire/ -- American Regent is conducting a voluntary nationwide recall to the user and consumer level of the following product:

Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial, Lot # 0362, Expiration Date: May 2012, NDC # 0517-2930-25

PLEASE NOTE:  This voluntary nationwide recall, initiated on June 14, 2011 to the user and consumer level is for lot # 0362 only. No other sizes or lots of Concentrated Sodium Chloride Injection, USP are subject to this voluntary recall.    

This voluntary recall was initiated because some of the vials of this lot contain visible particulates.  Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.  American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if this lot of product is administered to patients.  

Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs.  

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Concentrated Sodium Chloride Injection, USP, 23.4%, Lot # 0362 for patient care and should immediately quarantine any product for return.

As is standard practice, and as stated in the Concentrated Sodium Chloride Injection, USP Product Package Insert, "Parenteral drug products should b
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SOURCE Luitpold Pharmaceuticals, Inc.
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