Navigation Links
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

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,, 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:  

  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:  Mail to address on the pre-addressed form.

  • Fax: 1-800-FDA-0178

  • 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.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials
    2. American Scientific Resources Announces New Distributor Syner-Med Placing Kidz-Med VeraTemp in the United Kingdom and Ireland
    3. American Oriental Bioengineering to Announce Fourth Quarter and Full Year 2010 Financial Results on March 14, 2011
    4. Neuro Kinetics Presenting New Balance & Dizziness Research at American Balance Society Conference
    5. CVS Caremark and Universal American Announce Termination of Hart-Scott-Rodino Waiting Period
    6. Carmen Marc Valvo, Designer and Cancer Survivor, Teams Up With Dulcolax® and the Colon Cancer Alliance to Make it Fashionable for Americans to Get Screened
    7. MAP Pharmaceuticals to Present Data on LEVADEX™ at the 63rd Annual Meeting of the American Academy of Neurology
    8. American Medical Systems Announces U.S. Launch of Conceal™ Low Profile Reservoir for Penile Prosthetics
    9. High Rates of Pathological Complete Response in Patients with Advanced Esophageal Cancer in OPAXIO™ Phase II Study Reported in American Journal of Clinical Oncology
    10. American Legion: St. Louis VA Acted Quickly, Correctly
    11. Reportlinker Adds North American Pneumatic Accessories Market
    Post Your Comments:
    (Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
    (Date:11/26/2015)... , Nov. 26, 2015 Research and ... the "Advanced Wound Care Market by Type (Dressings, ... End User (In-Patient Facility, Out-Patient Facility), and Geography - ... --> --> ... description, definition and forecast of the global advanced wound ...
    (Date:11/26/2015)... ) has announced ... High Viscosity Drugs" report to their offering. ... addition of the "Self Administration of High ... --> Research and Markets ( ) ... Administration of High Viscosity Drugs" report to ...
    Breaking Medicine Technology:
    (Date:11/29/2015)... , ... November 29, 2015 , ... Khanna Vision Institute ... Board of Ophthalmology on November 25th 2015. Peer Certification by the Board is ... his specialty. Certification in Ophthalmology is first obtained after the completion of three years ...
    (Date:11/29/2015)... IL (PRWEB) , ... November 29, 2015 , ... Effective ... In addition starting on Black Friday Target is offering a “Buy One ... This is a rare opportunity to purchase IguanaMed at a discounted price. ...
    (Date:11/28/2015)... ... November 28, 2015 , ... Trying to relax on ... the COUCH BUDDY. "I conceived of this design due to personal experience with a ... users. It promotes relaxation and convenience, as well as increases support. It also makes ...
    (Date:11/27/2015)... Los Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... the conversation at the recent 2015 American Dental Association meeting in Washington D.C. revolved ... can help protect a patient’s overall health. The talk stressed the link between periodontal ...
    (Date:11/27/2015)... , ... November 27, 2015 , ... A team of ... ways to treat it. Surviving Mesothelioma has just posted the findings on the website. ... Hospital Zurich analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy ...
    Breaking Medicine News(10 mins):