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 the contents. DO NOT USE IF PARTICULATES ARE PRESENT.  USE A NEW VIAL.
  2. Use a 5 micron filter needle to withdraw the required calculated volume of Sodium Thiosulfate Injection, USP.
  3. Remove the filter needle and attach a standard needle to the syringe before adding to a larger volume of IV fluid and/or prior to patient administration.
  4. Visually inspect the final IV admixture solution.  DO NOT USE IF PARTICULATES ARE VISIBLE.  USE A NEW VIAL.
  5. Use a 0.22 micron in-line filter when administering the final IV admixture to patients.

If particulates are observed, or if you require additional information, please call American Regent at 1-877-788-3232 then press 2 for the Professional Services Department (Monday - Friday:  9:00am-5:00pm ET) or by e-mail at inquiry@americanregent.com

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm  

  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm . Mail to address on the pre-addressed form.

  • Fax: 1-800-FDA-0178

  • This letter is being distributed with the knowledge of the U.S. Food & Drug Administration.

    We apologize for any inconvenience that you may experience and appreciate your cooperation in this matter.

    Sincerely yours,

    Walter A. Tozzi, R.Ph., MS, MBA
    Sr. Director, Marketing & Professional ServicesSodiumThiosulfate Injection, USP

    Vial Sizes

    NDC #10% (100mg/mL)

    10mL SDV

    0517-1019-0525% (250mg/mL)

    50mL SDV

    0517-5019-01
    '/>"/>

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

    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:2/8/2016)... , Feb. 8, 2016  The University of ... announced today that, as part of the development ... of the first hospitals in the U.S. to start ... Muraszko , M.D., U-M,s chair of neurosurgery. ... neurosurgery. --> The BrightMatter technology from ...
    (Date:2/8/2016)... CITY, Calif., Feb. 8, 2016  Aoxing Pharmaceutical Company, Inc. (NYSE ... fiscal year 2016, ended December 31, 2015, the Company achieved ... recorded in the same quarter in fiscal 2015. ... in Q2 of fiscal year 2016 was $2,068,635, or $.03 ... or $.01 per share, in the Q2 of fiscal year ...
    (Date:2/8/2016)... Feb. 8, 2016 ... of the "Label-Free Detection Market by ... 2020" report to their offering. ... addition of the "Label-Free Detection Market ... to 2020" report to their offering. ...
    Breaking Medicine Technology:
    (Date:2/8/2016)... ... February 08, 2016 , ... Tingley Rubber ... Canada to provide its range of unique and advantaged protective solutions to ... that will provide bilingual customer service and marketing support. A new distribution center ...
    (Date:2/8/2016)... (PRWEB) , ... February 08, ... ... and security executive networking and relationship-marketing firm, announced today that nominations will ... Information Security Executive® (ISE®) West Awards. , Awards include the Information ...
    (Date:2/8/2016)... ... February 08, 2016 , ... GrassrootsHealth published data from its ... 2 diabetes in the GrassrootsHealth cohort with substantially higher vitamin D levels than ... public health,” states Carole Baggerly, Director of GrassrootsHealth, “the safety and benefits ...
    (Date:2/8/2016)... ... February 08, 2016 , ... The schedule is ... this country. The AutismOne 2016 Conference, which is being held May 25-29 at the ... hear elsewhere about helpful interventions and causes of chronic illness in children. , Very ...
    (Date:2/7/2016)... ... February 07, 2016 , ... Dr. Todd ... to his medical and surgical expertise. Technically known as deoxycholic acid or previously ... as a non-surgical alternative for reduction of fat below the chin (aka the ...
    Breaking Medicine News(10 mins):