Navigation Links
American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP
Date:2/3/2011

SHIRLEY, N.Y., Feb. 3, 2011 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:

Sodium Thiosulfate Injection, USP, 10% (100 mg/mL), 10 mL Single Dose Vial
NDC # 0517-1019-05
Lot #0056
Exp Date:  January, 2012



PLEASE NOTE:  This recall, initiated on February 2, 2011 to the User or Consumer Level, is for lot # 0056 Only. No other lots or sizes of Sodium Thiosulfate Injection, USP are subject to this voluntary recall.

This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination.  Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.  American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.

Sodium Thiosulfate Injection, USP is indicated in the treatment of cyanide poisoning.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use American Regent Inc., Sodium Thiosulfate Injection, USP, 10% (100mg/mL) 10 mL Single Dose Vial with lot # 0056 for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product.  Consumers/distributors/retailers that have product which is
'/>"/>

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

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/20/2013)... The Partnership at Drugfree.org , in ... the fourth annual Commissioner,s Play Healthy Awards ... the playing field. The awards are an extension of ... website, to educate families on the risks of ... and student athletes who embody the spirit of teamwork ...
(Date:6/20/2013)... Colo. , June 20, 2013 Sirtex ... today announced a sales and marketing partnership to distribute ... the interventional radiology and oncology markets. The agreement ... products in the company,s rapidly growing Asia Pacific ... Sirtex reported a 30 per cent growth in dose ...
(Date:6/20/2013)... 2013 Today Moscamed made the first ... a new programme to control the dengue mosquito Aedes ... of Bahia. In previous trials Moscamed have demonstrated ... reduce the number of dengue mosquitoes in a town. In ... mosquitoes were reduced by 96% within 6 months and it ...
Breaking Medicine Technology:Major League Baseball Charities and The Partnership at Drugfree.org Announce the Fourth Annual Commissioner's Play Healthy Awards 2Major League Baseball Charities and The Partnership at Drugfree.org Announce the Fourth Annual Commissioner's Play Healthy Awards 3Major League Baseball Charities and The Partnership at Drugfree.org Announce the Fourth Annual Commissioner's Play Healthy Awards 4Sirtex To Distribute Surefire Medical's Innovative Infusion System in Australia and Asia Pacific Markets 2Moscamed Launches Urban Scale Project Using Oxitec GM Mosquitoes in Battle Against Dengue 2Moscamed Launches Urban Scale Project Using Oxitec GM Mosquitoes in Battle Against Dengue 3
... -- Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: ... in the development, manufacturing, and marketing of branded and ... Mr. Hong Zhao, a highly regarded executive in the ... sales and marketing, effective February 12, 2011. ...
... Calif., Feb. 10, 2011 Renaissance Surgical Arts at Newport ... center in the Western United States to offer intraoperative radiotherapy ... in the TARGIT-A multicenter human clinical trial that demonstrated IORT ... with early breast cancer. IORT has the ...
Cached Medicine Technology:Simcere Pharmaceutical Group Appoints Industry Veteran Mr. Hong Zhao as Executive Vice President of Sales and Marketing 2Renaissance Surgical Arts at Newport Harbor Announces Single-Dose Radiation Treatment Alternative for Women with Early Breast Cancer 2Renaissance Surgical Arts at Newport Harbor Announces Single-Dose Radiation Treatment Alternative for Women with Early Breast Cancer 3
(Date:6/20/2013)... June 20, 2013 This ... focuses mainly on the oral and injectable ... report enumerates the various formulation technologies involved ... and advantages of specific technologies. Wherever possible, ... been discussed as proof of validation along ...
(Date:6/20/2013)... Beverly Hills, CA (PRWEB) June 20, 2013 ... David M. Amron, has been named by The Patient’s ... as an expert in liposuction, Dr. Amron will now ... Patient’s Guide. The Patient's Guide sees over one million ... provides information and articles related to plastic surgery and ...
(Date:6/20/2013)... Novatus Contract Management , the ... next release of upgrades and enhancements will be available ... system more robust, but continue to add investment value ... Online Negotiation Portal™ Interface enhancements – ... Portal from the outside. , Company Relationships ...
(Date:6/20/2013)... 20, 2013 Presenting at the ... society president and keynote speaker Dr. Rod ... future of rhinoplasty (plastic surgery of the nose) ... from across the nation. In his address, Dr. ... rhinoplasty to current open-technique rhinoplasty that reduces risk ...
(Date:6/20/2013)... weight may not reverse the damage that has been done ... even moderate weight loss can have a dramatic effect on ... within normal and healthy weight ranges is ideal, starting with ... shown to help relieve joint pain, as well as help ... have revealed that a weight loss of 11 pounds decreases ...
Breaking Medicine News(10 mins):Health News:Novel Drug Delivery Systems Market (NDDS): Formulations (Oral & Injectable) Analysis in Research Report at RnRMarketResearch.com 2Health News:Novel Drug Delivery Systems Market (NDDS): Formulations (Oral & Injectable) Analysis in Research Report at RnRMarketResearch.com 3Health News:Novel Drug Delivery Systems Market (NDDS): Formulations (Oral & Injectable) Analysis in Research Report at RnRMarketResearch.com 4Health News:Liposuction Guru, Dr. David Amron, Receives Award From The Patient’s Guide 2Health News:Novatus Contract Management Newest Enhancements and Upgrades to be Available July 1 2Health News:Dr. Rod J. Rohrich Delivers Keynote Address on the Future of Rhinoplasty 2Health News:Dr. Rod J. Rohrich Delivers Keynote Address on the Future of Rhinoplasty 3Health News:Dr. Rod J. Rohrich Delivers Keynote Address on the Future of Rhinoplasty 4Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Offers New Diet Plans, Now Capable of Helping Patient’s Avoid The Risk of Arthritis With Natural Weight Loss 2Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Offers New Diet Plans, Now Capable of Helping Patient’s Avoid The Risk of Arthritis With Natural Weight Loss 3
... SPRING, Md., Feb. 28 Celebrity chef Emeril,Lagasse joins ... top,quality food with viewers this summer in the new ... 24/7 eco-lifestyle,television network, is set to launch in June ... premiering throughout the summer, including,EMERIL GREEN (wt) which will ...
... TDP-43 mutations expose potential therapeutic target, experts say , , ... a new, yet rare, genetic mutation in the development ... only exposes a potential therapeutic target for treating the ... mutation sets in motion the mechanism that causes many ...
... and men are completely satisfied with the time they spend ... study published in the Journal of Family Issues. , ... be more time pressured than those who work part time ... professor of sociology at Kent State University. , In ...
... will Integrate IDC,s X1590 into the First Standardized ... ... /PRNewswire-FirstCall/ - IDC (Imaging Dynamics Company,Ltd.) (TSX: IDL), the global ... announced that Halifax Biomedical has selected,IDC,s X1590 as the DR ...
... PRINCETON, N.J., Feb. 28 Organizations,representing the state,s ... funding cuts proposed for hospital care for New ... $33 billion state spending plan for 2009, released,Tuesday, ... with funding of $608,million compared with current funding ...
... unlocked some of the mysteries of how the developing ... A present in the maternal blood stream. Their results ... Journal of Biological Chemistry. , The researchers studied ... formation of vitamin A stores in the body, during ...
Cached Medicine News:Health News:Emeril Lagasse and Planet Green Partner with Whole Foods Market(R) on Innovative New Series 2Health News:Emeril Lagasse and Planet Green Partner with Whole Foods Market(R) on Innovative New Series 3Health News:New Gene for Lou Gehrig's Disease Identified 2Health News:New Gene for Lou Gehrig's Disease Identified 3Health News:IDC X-Series DR system selected for use in leading edge RSA clinical trial application 2Health News:IDC X-Series DR system selected for use in leading edge RSA clinical trial application 3Health News:Hospital Groups United in Opposition to Charity Care Cuts 2Health News:Rutgers researchers unlock mysteries of vitamin A metabolism during embryonic development 2Health News:Rutgers researchers unlock mysteries of vitamin A metabolism during embryonic development 3