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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

ticulates 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 c'/>"/>

SOURCE Luitpold Pharmaceuticals, Inc.
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