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:1/23/2015)... 23, 2015  iMD Companies, Inc. (ICBU) has repositioned itself as ... and grab a foothold in the hydroponic, hemp and medical ... a presence in the sector, and recently partnering with the ... hemp and medical marijuana, iMD is committing to bring its ...
(Date:1/23/2015)... LAS VEGAS , Jan. 23, 2015 Cord Blood ... CBAI ) ("CBAI" or the "Company")  filed a Preliminary Proxy ... ( www.sec.gov ) today, and provides an update for shareholders ... authorized shares is requested. Dear Shareholders, ...
(Date:1/23/2015)... , Jan. 23, 2015  CytoSorbents Corporation (NASDAQ CM: ... CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation ... receipt of $385,642, net of transaction costs, in ... Technology Business Tax Certificate Transfer Program sponsored by ...
Breaking Medicine Technology:iMD Companies Poised to Make Impact in Multi-Billion Dollar Medical Marijuana Sector With Recent Investments and Strategic Partnerships 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 3Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 4CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3
... Mass., Aug. 31, 2011 Syndax Pharmaceuticals, Inc ... management will present at the following upcoming fall financial ... New York, NY, September 8 at 8:30 AM ET ... Zurich, Switzerland, September 13, 11:15 AM CEST oncology panel ...
... Fla., Aug. 31, 2011 A recent study featured ... dispels the myth that physicians, offices use prostate cancer ... The article, "Utilization Trends in Prostate Cancer ... of both surgical and radiation therapy for management of ...
Cached Medicine Technology:Syndax Pharmaceuticals to Present at Upcoming Fall Financial Conferences 2Study Explores Utilization Trends for Prostate Cancer Treatments 2
(Date:1/22/2015)... January 22, 2015 Yesterday, Senator ... (D-Concord) and Kristin Olsen (R-Modesto) were honored by ... in advancing biotechnology, biomedical science, medical device and ... each received the “2014 Life Sciences Champion” award ...
(Date:1/22/2015)... years since the release of their debut recording Love is King, ... & Matthew Love – the duo are pleased to announce their ... Swan Records on February 24, 2015. , THE ROAD offers the ... all of us to walk out of the mire of our ...
(Date:1/22/2015)... January 22, 2015 As interest in the ... care gains momentum worldwide, Rev. Eric J. Hall , ... Network (HCCN), will be the keynote speaker on January ... Israel’s public health system. , The conference, “Hope and Resilience: ...
(Date:1/22/2015)... 22, 2015 Lower-Auto-Insurance.com has released a new blog ... a car for reducing the costs of an auto insurance ... be able to get lower prices for their vehicle insurance policies. ... role in determining policy costs. Because of this, drivers should ...
(Date:12/26/2014)... (PRWEB) December 26, 2014 The US represents ... this report. In 2013, GlobalData’s forecast estimates that sales of ... CRC market due to the high incidence of the disease, ... the 5EU, Japan, and China. Increased sales of CRC therapies ...
Breaking Medicine News(10 mins):Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 3Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 4
... 22 (HealthDay News) -- New research offers insight into ... syndrome. Researchers from the University of Adelaide in ... the colon. This contributes to relief of pain from ... shows that peppermint acts through a specific anti-pain channel ...
... -- (Bronx, NY) -- Transplanting cells from healthy adult livers ... millions of people worldwide, according to an animal study in ... Clinical Investigation . Jayanta Roy-Chowdhury, M.D. , professor ... Albert Einstein College of Medicine of Yeshiva University, ...
... An article in Science Signaling by researchers ... (RCAI) has clarified for the first time the mechanism ... The finding establishes a role for the extracellular signal-regulated ... key step toward the development of B cell-targeted drugs ...
... that pulmonary administration of granulocyte macrophage-colony stimulating factor (GM-CSF) ... lethal dose influenza virus. While GM-SCF therapy for humans ... away, the study results were striking: All of the ... the influenza virus, whereas untreated mice all died from ...
... By Randy Dotinga HealthDay Reporter , THURSDAY, ... hemodialysis to kidney failure patients through a central line ... risk of death shortly after beginning dialysis, a new ... more than 38,500 Canadian patients who began dialysis from ...
... Reporter , THURSDAY, April 21 (HealthDay News) -- Just like ... the gut can also be used to categorize humans, new ... three distinct types of microscopic ecosystems that exist in the ... microbes are present and which are the most abundant, researchers ...
Cached Medicine News:Health News:Liver-cell transplants show promise in reversing genetic disease affecting liver and lungs 2Health News:Signaling pathway reveals mechanism for B cell differentiation in immune response 2Health News:New approach to defeating flu shows promise 2Health News:New approach to defeating flu shows promise 3Health News:Higher Death Rates Seen in Central Line Dialysis Patients: Study 2Health News:Gut Bacteria Falls Into Three Major Types 2Health News:Gut Bacteria Falls Into Three Major Types 3
Includes conservation device, matched regulator, standard supply tubing, cannula, carrying case, batteries, and instruction booklet....
... Control Catheter with Accutrol is similar in ... except that it incorporates a temperature probe ... The temperature probe can accurately determine the ... catheter provides temperature accuracy comparable to a ...
... Through A 1.0mm Incision., ,Special Direct Acting ... Improved ... Approach., ,Recessed Jaws For Improved Sub-Incisional Flap ... Jaws During Sterilization., ,Reusable, Autoclaveable, Guaranteed For ...
... Special Reverse-Action Forceps Design With Spreading Spatula ... The Spreading & Lifting Of Corneal Flaps Created ... ,The Spatula Tips Of ... The Corneal Flap. Once Access Is Achieved, ...
Medicine Products: