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American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials

Tue, 03/15/2011 - 10:32am
Bio-Medicine.Org

SHIRLEY, N.Y., March 15, 2011 /PRNewswire/ -- American Regent is conducting a voluntary nationwide recall of the three lots listed below of the following product:

Bacteriosatic Sodium Chloide Injection, USP, 0.9%, 30 mL, Multiple Dose VialsNDC# 0517-0648 -25PLEASE NOTE:  This voluntary nationwide recall, initiated on March 15, 2011 to the User Level, is for the following lots of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials:NDC # 0517-0648-25Lot#ExpirationDateFirstDistributionDate9330

05/2011

06/18/20099599

08/2011

10/12/20099828

12/2011

03/16/2010This voluntary recall was initiated because some of the vials of these lots may 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 these lots of product are administered to patients.

The product was distributed to wholesalers and distributors nationwide.

Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used for preparing and diluting sterile solutions.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Bacteriostatic Sodium Chloride Injection, USP, 30 mL Multiple Dose Vials with the lot #s listed above for patient care and should immediately quarantine any product for return.

American Regent has identified the source of the par

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