, March 15, 2011
American Regent is conducting a voluntary nationwide recall of the three lots listed below of the following product:
Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL, Multiple Dose Vials
PLEASE 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 # 0517-0648-25
This 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 inspectedvisually forparticulatematterand discoloration prior toadministration, wheneversolutionandcontainerpermit."
AmericanRegentwill creditaccountsfor all returned productwith these lot #s.Those with questionsabout thereturnor recallprocess, pleasecall our CustomerServiceDepartment at1-877-788-3232:MondaythruFridayfrom8:30AM to7:00PMET.
Hospitals, emergency rooms, infusion centers, clinicsandhealthcareproviders,orpatients withproduct qualitycomplaints, medicalor otherquestions concerningthe useofthe productorreasonsforthisrecallshouldcontacttheProfessionalServicesDepartmentat
Anyadverse reactions experiencedwiththe use of this product should be reported to
AmericanRegent,Inc.viaemailatPV@luitpold.com, byfax to(610)650-7781or (610)
650-0170or by phoneat1-800-734-9236. TOEXPEDITEHANDLINGPLEASEDONOT REPORT ANYTHINGOTHERTHANSPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR 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.
Bacteriostatic Sodium Chloride Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
SOURCE Luitpold Pharmaceuticals, Inc.