Navigation Links
Important Drug Information Notice Regarding Sodium Thiosulfate Injection, USP, 10% (100mg/mL), 10mL Single Dose Vials and 25% (250mg/mL), 50mL Single Dose Vials
Date:3/29/2011

SHIRLEY, N.Y., March 29, 2011 /PRNewswire/ -- Yesterday American Regent, Inc. issued a letter regarding a product recall from February 2011. The text of the letter follows:

Dear Healthcare Professional,

Recently, American Regent, Inc. recalled Sodium Thiosulfate Injection, USP, 10%, 10mL Single Dose Vials, Lot #0056, because some of the vials of this lot contained translucent visible particles that have been identified as glass delamination.  The particles detected in Lot #0056 ranged in size from < 5 microns to about 350 microns.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.  American Regent recalled Sodium Thiosulfate Injection lot #0056 on February 2, 2011 in consideration of the potential for safety issues if this lot of product was administered to patients.

Retention samples of all other lots and sizes of this product in commercial distribution (see below for sizes and NDC #s) have been visually re-inspected and have not exhibited visible evidence of glass delamination or translucent visible particles indicative of glass delamination.  Our retention inspection program requires samples be visually inspected at appropriate intervals to ensure there is no evidence of deterioration in our products.  American Regent has already taken other steps, such as changing the source of glass used, to help address this problem.

As a precautionary measure, American Regent recommends that, until further notice, a filter be used for the withdrawal and administration of this product.  

The following procedure should be used for the compounding and administration of Sodium Thiosulfate Injection, USP (this does not apply to the recalled Lot #0056, which should not be administered).

  1. Perform a visual inspection on the vial prior to withdrawal of t
    '/>"/>

SOURCE American Regent, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Important Drug Information Notice Regarding Potassium Phosphates Injection, USP, 3 mM/mL Phosphorous; 4. 4 mEq/mL Potassium: 5 mL, 15 mL and 50 mL Single Dose Vials
2. PNP Therapeutics Meets Important Financial and Regulatory Objectives in Development of New Cancer Therapies
3. Urgent: OTC DRUG Nationwide Recall--Important information for patients about IV PREP Antiseptic Wipes
4. ICAP Ocean Tomo Announces Four Patent Sets From Oxford Instruments - Each Represents an Important Advancement in Technology
5. Avantra Biosciences and MedTrust Online Partner to Develop Clinically Important Protein Biomarker Assays for Improving Cancer Care
6. Ardea Biosciences Earns $15 Million Payment from Bayer HealthCare AG for Achievement of Important Clinical Milestone in Ongoing Collaboration
7. Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Groups Alcohol Prep Products
8. AVMA Offers Important Guidance to DEA on New Controls for Induction Agent—Propofol
9. Activity Against Key Drug-Resistant Pathogens is the Most Important Attribute Influencing Surveyed Physicians Antibiotic Selection for Nosocomial Pneumonia in the U.S.
10. Cardium Announces New Research Findings: Excellagen Product Candidate Activates Platelet Release of PDGF, an Important Growth Factor Fundamental to the Wound Healing Process
11. Global Med Technologies(R) Solution of Choice for Important Regional Blood Center
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... , Sept. 18, 2014  KIYATEC announced today ... Small Business Innovation Research (SBIR) Phase II Contract ... the 27 institutes and centers that comprise the ... of the two year award, KIYATEC will expand ... issues at the forefront of cancer therapy strategies: ...
(Date:9/18/2014)... LONDON , September 18, 2014 ... their audience, has updated the incredibly successful Serialisation Countdown ... The interactive PDF, available at pharmaserialisation.com shows ... in which they will be coming into force. ... no longer a matter of "if", but "when" they ...
(Date:9/18/2014)... ARBOR, Mich. , Sept. 18, 2014  A ... Research will allow the University of Michigan to establish ... The Glenn Center for Aging Research at ... evidence that drugs can slow the effects of aging ... unlock mechanisms of aging that can help develop medications ...
Breaking Medicine Technology:National Cancer Institute Awards KIYATEC Nearly $2M to Advance Predictive Cancer Diagnostics 2National Cancer Institute Awards KIYATEC Nearly $2M to Advance Predictive Cancer Diagnostics 3Pharma IQ Displays Worldwide Serialisation Deadlines in their 2014 - 2018 Countdown Calendar 2$3 M grant funds Paul F. Glenn Center for Aging Research at the University of Michigan 2$3 M grant funds Paul F. Glenn Center for Aging Research at the University of Michigan 3
(Date:9/18/2014)... living in disadvantaged neighborhoods have worse musculoskeletal pain ... motor vehicle collision than individuals from higher socioeconomic ... such as age, sex, income, education, and employment ... multi-site research study led by Samuel McLean, MD, ... at the University of North Carolina School of ...
(Date:9/18/2014)... September 18, 2014 It is almost time ... or walk for healthier and happier kids. The South ... in the 4th Annual Miami Children’s Hospital 5K Run/Walk. ... http://www.hyundaihopeonwheels.org , The 5K will take place on ... be outside of Coral Gables City Hall located at 405 ...
(Date:9/18/2014)... Good Neighbor Pharmacy, a national independent ... Pharmacy University, an online central resource for network ... empower pharmacy owners and their staff in today’s ... evolve, Good Neighbor Pharmacy is a partner to ... to help their businesses thrive,” said Scott Robinson, ...
(Date:9/18/2014)... parents eat more vegetables and drink less sugar, according ... Columbia. But it,s still not enough, the study goes ... when it comes to eating healthier at school , ... of socioeconomic status, may inform a child,s diet. , ... some post-secondary education were 85 per cent more likely ...
(Date:9/18/2014)... Relias Learning, the leader in SaaS-based training and ... announced it has been named to the Inc. 5000 list ... , In the three-year period from 2010 to 2013, Relias ... on the Inc. 5000 list to 1,025 from the company’s ... we serve continue to grow, and the need for quality ...
Breaking Medicine News(10 mins):Health News:Living in a disadvantaged neighborhood worsens musculoskeletal pain outcomes after trauma 2Health News:South Florida Hyundai Dealers Association Proudly Support the 4th Annual Miami Children’s Hospital 5K Run/Walk this Saturday August 20th in Coral Gables 2Health News:South Florida Hyundai Dealers Association Proudly Support the 4th Annual Miami Children’s Hospital 5K Run/Walk this Saturday August 20th in Coral Gables 3Health News:Good Neighbor Pharmacy University Keeps Pharmacists Ahead of the Curve 2Health News:Kids eat better if their parents went to college 2Health News:Relias Learning Named to Inc. 5000 List for Second Consecutive Year 2
... (Nov. 3, 2011) Because the incidence of malignant ... the U.S., researchers at Moffitt Cancer Center in Tampa, ... Carolina University and the University of Arizona are working ... malignant melanoma diagnosis and therapy. A tool of great ...
... Reinberg HealthDay Reporter , WEDNESDAY, Nov. 2 ... therapy prolongs survival among men whose cancer has spread ... These men have what is called high-risk, or locally ... to 25 percent fall into this category. In the ...
... 3 (HealthDay News) -- The first artificial heart valve ... approved by the U.S. Food and Drug Administration. ... an aortic heart valve damaged by senile aortic valve ... deposits that cause the valve to narrow. One ...
... Severe early childhood caries can destroy most of a ... populations, including American Indians and Alaskan natives. Although the ... early childhood caries has been known for almost a ... are responsible for the disease has remained elusive. ...
... (HealthDay News) -- Allergy shots are time-tested treatments ... relief to allergy sufferers within weeks instead of months, ... currently given under the skin (subcutaneously), new methods of ... week,s annual scientific meeting of the American College of ...
... , WEDNESDAY, Nov. 2 (HealthDay News) -- A compound currently ... hemophilia patients also seems to be effective in preventing bleeds ... in the Nov. 3 edition of the New England ... last long, the results do raise the possibility that, over ...
Cached Medicine News:Health News:Researchers help in search for new ways to image, therapeutically target melanoma 2Health News:Radiation Plus Hormone Therapy Extends Life in High-Risk Prostate Cancer 2Health News:Radiation Plus Hormone Therapy Extends Life in High-Risk Prostate Cancer 3Health News:FDA OKs Heart Valve That Does Not Require Open-Heart Surgery 2Health News:FDA OKs Heart Valve That Does Not Require Open-Heart Surgery 3Health News:NYUCD awarded $2.2 million NIH grant to decode genome of caries-causing bacteria 2Health News:NYUCD awarded $2.2 million NIH grant to decode genome of caries-causing bacteria 3Health News:Improved Allergy Shots Might Be on Horizon 2Health News:Using Drug for Prevention Might Help in Hard-to-Treat Hemophilia 2Health News:Using Drug for Prevention Might Help in Hard-to-Treat Hemophilia 3
... offer the physician a new approach to supportive ... The weight simply uses gravity to gently close ... or when the eyelid muscle is relaxed. ... variety of skin tone colors to match a ...
... Heidelberg Multi Color (HMC) ... a microprocessor-controlled precision assessment ... the red/green range (Rayleigh ... (Moreland equation) with integrated ...
... VersaSuite practice management software is ... the business and clinical aspects of ... solution offers support for the financial, ... the eye care professional. Designed as ...
... in our country to provide greater and ... recent government regulations require it. The Access ... your wheelchair-bound patients easy and comfortable access ... to leave their wheelchair. , ,The Access ...
Medicine Products: