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American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials
Date:3/15/2011

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 particulates and has taken the necessary steps to correct this issue. The company is initiating this voluntary recall for these lots manufactured prior

to the implementation of this corrective action. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Bacteriostatic Sodium Chloride Injection, USP Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."

AmericanRegenwill crediaccountsfor all returned producwith these lot #s.Those wih questionsabout thereturnor ecallprocess, pleasecall our CustomerServiceDepartment at1-877-788-3232:MondayhruFridayfrom8:30AM to7:00MET.Hositals, emegency rooms, infusion centers, clinicsandhealthcareoviders,opatients withproducqualitycomplains, medicalooherquestions conceningthe useofthe productoreasonsforthisecallshouldconactheProfessionalServicesDeparmentat1-877-788-3232.Anyadvese reactions experiencedwiththe use of this poduct should be reported toAmericanRegent,Inc.viaemailatPV@luitpold.com, byfax o(610)650-7781or (610)650-0170oryhoneat1-800-734-9236.  TOEXPEDITEHANDLINGPLEASEDONOT REPO ANYTHINGOTHETHANSPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX O PHONE.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm

  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

  • Fax: 1-800-FDA-0178

  • Bacteriostatic Sodium Chloride Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).


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    SOURCE Luitpold Pharmaceuticals, Inc.
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