Navigation Links
American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
Date:6/15/2011

SHIRLEY, N.Y., June 15, 2011 /PRNewswire/ -- American Regent is conducting a voluntary nationwide recall to the user and consumer level of the following product:

Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial, Lot # 0362, Expiration Date: May 2012, NDC # 0517-2930-25

PLEASE NOTE:  This voluntary nationwide recall, initiated on June 14, 2011 to the user and consumer level is for lot # 0362 only. No other sizes or lots of Concentrated Sodium Chloride Injection, USP are subject to this voluntary recall.    

This voluntary recall was initiated because some of the vials of this lot 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 this lot of product is 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%, Lot # 0362 for patient care and should immediately quarantine any product for return.

As is standard practice, and as stated in the Concentrated Sodium Chloride Injection, USP Product Package Insert, "Parenteral drug products should b
'/>"/>

SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. American Medical Systems Announces Large-Scale, Physician-Led Registry of Penile Implants
2. Unity Management Group, MCC Announce Increased Contracts and Major Installations at US and South American Pharmaceutical Companies
3. Thomson Reuters - NPR Health Poll Finds Three-Quarters of Americans Support Government Insurance Subsidies for Birth Control Pills
4. American Scientific Resources Will be a Presenter at the Undiscovered Equities Spring Conference in Boca Raton
5. NKTR-102 Demonstrates Sustained Clinical Benefit in 46% of Patients with Metastatic Breast Cancer in Data Presented at 2011 American Society of Clinical Oncology Annual Meeting
6. Genomic Health Presents Ten New Studies in Breast, Colon and Prostate Cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting
7. Translational Sciences Corporation to Launch OncoTrac™ at the American Society of Clinical Oncology (ASCO) Annual Meeting
8. American Scientific Resources, Inc. Announces Dismissal of Sanomedics International Holdings, Inc. lawsuit
9. American Scientific Resources, Inc. Announces Quarterly Results
10. Omron Healthcare Announces Donation to the American Society of Hypertension, Inc.
11. American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP, 50 mL Single Dose Vial Due to Particulate Matter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... 27, 2015  PinnacleHealth CardioVascular Institute enrolled the first patient ... the United States in a trial assessing ... for blockages in the main artery of the leg. The ... potentially less risk for stent fracture or re-narrowing after the ... multicenter clinical trial of the BioMimics 3D Stent System and ...
(Date:8/27/2015)... YORK , August 27, 2015 ... published by Persistence Market Research titled "Global Market ... Witness Highest Growth by 2021", the urinary catheters market is ... the end of 2015. It is anticipated to ... 2021, to reach US$1,755.0 Mn by 2021. ...
(Date:8/27/2015)... 2015  QB3@953—a San Francisco ... California (UC) research institute and biotech accelerator— today ... identify and facilitate collaborations to translate early drug ... The agreement formalizes a relationship between QB3@953 ... and creates a new channel for DPAc to ...
Breaking Medicine Technology:First Pennsylvania Patient Treated in Landmark Vascular Study 2Global Urinary Catheters Market Will Reach US$1,755.0 Mn by 2021: Persistence Market Research 2Global Urinary Catheters Market Will Reach US$1,755.0 Mn by 2021: Persistence Market Research 3Global Urinary Catheters Market Will Reach US$1,755.0 Mn by 2021: Persistence Market Research 4QB3@953 Signs Collaboration Agreement with GSK to Identify Early-Stage Drug Discovery Opportunities 2
... Berger Health System, recognized as one of the ... to AutoCarousel® HD by Talyst, a leader of pharmacy ... has a built-to-last 10 years guarantee. Berger ... is also implementing AutoPharm®, AutoPack™ and AutoLabel® to help ...
... Lineagen, Inc., an innovative molecular diagnostics company focused on ... nonprofit subsidiary of the National Multiple Sclerosis Society, today ... validation of a blood-based assay for multiple sclerosis (MS). ... test that can aid clinicians in diagnosing MS, distinguishing ...
Cached Medicine Technology:Berger Health System Partners With Pharmacy Automation Leader to Improve Patient Safety 2Lineagen and Fast Forward Collaborate to Develop Gene and Biomarker-Based Clinical Assays for Multiple Sclerosis 2Lineagen and Fast Forward Collaborate to Develop Gene and Biomarker-Based Clinical Assays for Multiple Sclerosis 3Lineagen and Fast Forward Collaborate to Develop Gene and Biomarker-Based Clinical Assays for Multiple Sclerosis 4
(Date:8/27/2015)... ... August 27, 2015 , ... Cytovance® Biologics, ... biopharmaceutical contract development manufacturing company (CDMO), announced today that it has entered into ... in cash. , The addition of Cytovance Biologics to Hepalink USA ...
(Date:8/27/2015)... ... 27, 2015 , ... Susan Harris and the team at LifeStream ... to pre- and post-menopause, chemotherapy, and child birth. , The MonaLisa Touch ... to the vaginal tissue, revitalizing cells so they make more collagen, an essential component ...
(Date:8/27/2015)... Rocky Hill, CT (PRWEB) , ... August 27, 2015 , ... ... Portal Companies List. , “The companies selected have the platforms required not only to ... training,” said Ken Taylor, President of Training Industry, Inc. , For six consecutive ...
(Date:8/27/2015)... ... August 27, 2015 , ... ... firm that helps libraries, publishers and companies leverage key operational, technical, business ... the VIVO Project. Gunter Media Group, Inc., will provide VIVO related services ...
(Date:8/27/2015)... Newport Beach, CA (PRWEB) , ... August 27, ... ... services and products, announced today that the new issue of Chairside® magazine, its ... the latest issue, Volume 10, Issue 3, as well as past issues of ...
Breaking Medicine News(10 mins):Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 2Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 3Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 4Health News:LifeStream Health Centre & MedSpa Announces New Treatment for Vaginal Discomfort 2Health News:LifeStream Health Centre & MedSpa Announces New Treatment for Vaginal Discomfort 3Health News:NetDimensions Named Among Top 20 Learning Portal Companies of 2015 2Health News:NetDimensions Named Among Top 20 Learning Portal Companies of 2015 3Health News:DuraSpace Selects Gunter Media Group, Inc. as a Registered Service Provider for VIVO 2Health News:DuraSpace Selects Gunter Media Group, Inc. as a Registered Service Provider for VIVO 3Health News:Glidewell Laboratories Releases Latest Issue of Restorative Dentistry Magazine Chairside in Print and Online 2Health News:Glidewell Laboratories Releases Latest Issue of Restorative Dentistry Magazine Chairside in Print and Online 3
... , , BATESVILLE, Ind., and ... today announced a strategic partnership agreement to integrate the Radianse ... system. With this move, Hill-Rom intends to extend its ... financial and technical obstacles for health care customers as they ...
... NOVATO, Calif., Sept. 2 BioMarin Pharmaceutical Inc. (Nasdaq: ... Chief Financial Officer of BioMarin, will present a company update at the ... at 4:25 p.m. ET. , , Interested ... the investor section of the BioMarin website, www.BMRN.com . ...
... SOMERSET, N.J., Sept. 2 Meda Pharmaceuticals ... (FDA) has approved ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, for ... rhinitis (SAR and PAR). New ASTEPRO Nasal Spray 0.15% ... for patients who suffer from seasonal allergies. ASTEPRO Nasal Spray ...
... /PRNewswire-Asia/ -- RainEarth Inc.,(OTC Bulletin Board: RNER; "the Company") announced ... publicized the creation of "Opinions of the,CPC Central Committee and ... Health Care System" ("Opinion"). , The ... a,doctor more easily. Reduced cost is the short-term goal and ...
... , , , , ... Mass., Sept. 2 /PRNewswire-FirstCall/ -- ... company that is developing and marketing Levulan(R) Photodynamic Therapy (PDT) and ... Bob Doman, President and Chief Executive Officer, will present a corporate ...
... , , , ... , a medical device company, today announced that its ... the U.S. Food and Drug Administration (FDA) for the direct delivery ... may be in the treatment of cancer. , , ...
Cached Medicine News:Health News:Hill-Rom and Radianse Announce Partnering Agreement to Integrate Location-Sensing Technology into NaviCare(R) Nurse Call 2Health News:Hill-Rom and Radianse Announce Partnering Agreement to Integrate Location-Sensing Technology into NaviCare(R) Nurse Call 3Health News:Hill-Rom and Radianse Announce Partnering Agreement to Integrate Location-Sensing Technology into NaviCare(R) Nurse Call 4Health News:BioMarin to Present at the Thomas Weisel Partners Healthcare Conference 2Health News:MEDA Receives FDA Approval of New ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine 2Health News:MEDA Receives FDA Approval of New ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine 3Health News:MEDA Receives FDA Approval of New ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine 4Health News:MEDA Receives FDA Approval of New ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine 5Health News:RainEarth (RNER) Complies with Chinese Medical Service Reforms to Provide Better and Cheaper Blood Dialysis 2Health News:RainEarth (RNER) Complies with Chinese Medical Service Reforms to Provide Better and Cheaper Blood Dialysis 3Health News:DUSA Pharmaceuticals to Present at the Rodman & Renshaw 11th Annual Healthcare Conference 2Health News:Potential Breakthrough Cancer Treatment Now Available From Vascular Designs 2Health News:Potential Breakthrough Cancer Treatment Now Available From Vascular Designs 3Health News:Potential Breakthrough Cancer Treatment Now Available From Vascular Designs 4
Cocoon Disposable Patient Warming Blankets are specially designed to prevent hypothermia and maintain normothermia in your patients. The soft warm coloured material is strong and resists tearing and ...
Similar to Model 530, but just 37 inches long and with only one drape....
2-ply material consisting of polyethylene film inner layer and non-woven outer layers....
Cocoon Disposable Patient Warming Blankets are specially designed to prevent hypothermia and maintain normothermia in your patients. The soft warm coloured material is strong and resists tearing and ...
Medicine Products: