SHIRLEY, N.Y., March 15, 2011 /PRNewswire/ -- American Regent is conducting a voluntary nationwide recall of the following products:ConcentatedSodium Chloide Injection, USP, 23.4%, 30 mL Single Dose Vial NDC# 0517-2930-25andConcentatedSodiumChlorideInjection,USP, 23.4%,100 mL PharmacyBulkackage NDC# 0517-2900-25PLEASE NOTE: This voluntary nationwide recall, initiated on March 15, 2011 to the User Level, is for Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages. See attached APPENDIX for ALL the lots subject to this recall.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.
Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs.
The product was distributed to wholesalers 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.Hositals, emegency rooms, infusion centers, clinicsandhealthcareoviders,opatients withproducqualitycomplains, medicalooherquestions conceningthe useofthe productoreasonsforthisecallshouldconactheProfessionalServicesDeparmentat 1-877-788-3232.Anyadvese reactions experiencedwiththe use of this poduct should be reported to AmericanRegent,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.
Concentrated Sodium Chloride Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
APPENDIXRecalledLotsof Concentrated Sodium Chloide Injection, USP, 23.4%ConcentatedSodium Chloide Injection, USP, 23.4%, 30 mL Single Dose VialNDC# 0517-2930-25Lot #Expiration DateFirst DistriutionDate9198
03/17/2010ConcentatedSodiumChlorideInjection,USP, 23.4%,100 mL PharmacyBulkackageNDC# 0517-2900-25Lot #Expiration DateFirst DistriutionDate9225
|SOURCE Luitpold Pharmaceuticals, Inc.|
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