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:8/21/2014)... 2014   Memorial Hermann Health System and ... announced a new partnership to provide a new level of ... centers in the greater Houston area. ... the exclusive provider of professional breast radiology services for five ... City, The Woodlands , Northeast, Southwest and ...
(Date:8/21/2014)... 2014 The spinal column is one of the ... carried to and from the brain through the column control ... Injury or ailment here can be life altering, and leave ... control over their body. Though back injury and disease can ... are more options available to make things better than ever ...
(Date:8/21/2014)... BURLINGTON, Mass. , Aug. 21, 2014 /PRNewswire/ ... of COPD,  physicians in Brazil ... to follow clinical guidelines and commonly prescribe long-acting ... regimens, although they do so within current severe ... combinations (FDCs) that are expected to launch in ...
Breaking Medicine Technology:Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 2Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 3Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 4Don't Live in Pain: Four Life Improving Benefits of Back Surgery 2Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms 2Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms 3
... March 14, 2011 Bionovo, Inc. (Nasdaq: BNVI ) ... quarter of fiscal year 2010 ended December 31, 2010 on Tuesday, ... webcast to review the financial results on Tuesday, March 15, 2011, ... call by dialing 1-888-428-7458, or can listen via a live audio ...
... /PRNewswire-Asia-FirstCall/ -- China-Biotics, Inc. (Nasdaq: CHBT ) ... distributor of probiotics products in China, today announced the ... held on Wednesday, March 9, 2011 for stockholders of ... Offices at No. 26, Orient Global Headquarter, Lane 118 ...
Cached Medicine Technology:China-Biotics, Inc. Announces the Results of the 2010 Annual Meeting of Stockholders 2
(Date:8/23/2014)... (PRWEB) August 23, 2014 Teen drug ... Carolina. It’s no different in Wilmington, NC. Substance abuse ... are falling victim to drug and alcohol dependency in ... are looking to overcome substance abuse, but don’t know ... adolescent treatment facility can be a challenge because most ...
(Date:8/22/2014)... The IT manager of Top10BestSEOHosting.com is a web ... He has recently announced that GoDaddy ( http://www.top10bestseohosting.com/go/GoDaddy.com/ ) ... , GoDaddy is a popular supplier of cheap web ... solutions at affordable rates. It offers three Linux shared ... depend on the length of the contract. The longest ...
(Date:8/22/2014)... Today, Zane Benefits, the #1 Online ... Health Plans. , According to Zane Benefits, employers are ... lower the cost of healthcare without reducing coverage for ... however, can be confusing. , The new guide contains ... main types of ABHPs. It also explains the ...
(Date:8/22/2014)... Recently, UWDress.com, a leading online supplier of ... new range of empire bridesmaid dresses to its ... a summer promotion for these high quality items. All of ... to 75 percent off. , The company’s new items ... efficient assistance on its website. It is true that all ...
(Date:8/22/2014)... Jose, CA (PRWEB) August 22, 2014 ... now offering a new teeth whitening technique. Air polishing ... regular cleaning appointments. , Dark teeth can be caused ... two categories: external stains and internal stains. External stains ... stains can be caused by certain medications, such as ...
Breaking Medicine News(10 mins):Health News:Troubled Teens Wilmington Helpline Guides Adolescents to the Path of Recovery 2Health News:Discounted Empire Bridesmaid Dresses Online At UWDress.com 2Health News:Japantown Dental Introduces Air Polishing 2
... The national recession didn,t just hit people living in the ... pay for medical bills in poor countries like Honduras, according ... opportunities have dried up for Latino immigrants in the U.S., ... ill family members in their home countries, according to a ...
... chemotherapy have dramatically improved the outlook for many cancer ... daunting. A new generation of chemotherapy drugs with fewer ... assistant professor of chemistry at the University of Cincinnati. ... these new anticancer agents Tuesday, March 27, at The ...
... MONDAY, March 26 (HealthDay News) -- Women should be ... death among women in the United States -- during ... study suggests. Researchers from Mount Sinai Medical ... performed during visits to obstetrician/gynecologists could help identify women ...
... study presented at the Society of Interventional Radiology,s 37th ... light at the end of the tunnel for individuals ... procedure called irreversible electroporation or IRE uses microsecond electrical ... a vast and delicate network of blood vessels of ...
... launched a major clinical trial to investigate whether eliminating a ... in some patients. The Helicobacter Eradication Aspirin ... Helicobacter pylori in the gut of patients taking ... chances of developing a stomach ulcer and dangerous associated bleeding ...
... that very few young women with cancer take steps to ... of young women are more likely to do so than ... journal of the American Cancer Society, the study indicates that ... reproductive-aged women diagnosed with cancer. More than 120,000 women ...
Cached Medicine News:Health News:US economic woes ripple all the way to Latin America, U-M study shows 2Health News:Progress toward new chemotherapy agents 2Health News:Ob/Gyn Visit a Good Time to Screen for Heart Disease: Study 2Health News:Electrical pulse treatment gives pancreatic cancer patients new hope 2Health News:Can eradicating a common stomach bug make taking aspirin safer? 2Health News:Few young women with cancer take steps to preserve fertility during treatments 2
... cannula which contains a coaxial 12 Fr ... Basket and a Tip Deflecting Wire Guide. ... cannula to carry these two instruments, via ... (Requires a Handle for Tip Deflecting Wire ...
The only solution for in-line digital measurement...
PEACOCK from NOMOS is a complete treatment,planning and delivery system exclusively designed,to support intensity modulated radiation therapy,(IMRT). PEACOCK is comprised of two breakthrough,...
... dedicated system for non-invasive ... (SRS/SRT), represents cutting-edge technology ... of brain as well ... tumors, arteriovenous malformations and ...
Medicine Products: