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American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs
Date:3/15/2011

holesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Concentrated Sodium Chloride Injection, USP, 23.4% with the lot #s on the attached Appendix 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 Concentrated 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.
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SOURCE Luitpold Pharmaceuticals, Inc.
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