Navigation Links
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
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 Potassium Phosphates Injection, USP, 5mL Single Dose Vial, Lot# 0048, because some of the vials of this lot contained translucent visible particles that have been identified as glass delamination.  The particles detected in Lot #0048 ranged in size from < 5 microns to about 540 microns.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.  American Regent recalled Potassium Phosphates Injection, lot #0048 on February 3, 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 Potassium Phosphates Injection, USP (this does not apply to the recalled Lot #0048, 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 Potassium Phosphates 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 prior to patient administration.  NOTE:  Potassium Phosphates Injection, USP is administered intravenously only after further dilution in a larger volume of IV fluid.
  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.
  6. For lipid containing admixtures, the use of a 1.2 micron in-line filter is recommended.

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 ServicesPotassium Phosphates Injection, USP

    Vial Sizes

    NDC #15mM/5mL Phosphorous; 22mEq/5mL Potassium

    5mL SDV

    0517-2305-2545mM/15mL Phosphorous; 66mEq/15mL Potassium

    15mL SDV

    0517-2315-25150mM/50mL Phosphorous; 220mEq/50mL Potassium

    50mL SDV

    0517-2350-25
    '/>"/>

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

    Related medicine technology :

    1. PNP Therapeutics Meets Important Financial and Regulatory Objectives in Development of New Cancer Therapies
    2. Urgent: OTC DRUG Nationwide Recall--Important information for patients about IV PREP Antiseptic Wipes
    3. ICAP Ocean Tomo Announces Four Patent Sets From Oxford Instruments - Each Represents an Important Advancement in Technology
    4. Avantra Biosciences and MedTrust Online Partner to Develop Clinically Important Protein Biomarker Assays for Improving Cancer Care
    5. Ardea Biosciences Earns $15 Million Payment from Bayer HealthCare AG for Achievement of Important Clinical Milestone in Ongoing Collaboration
    6. Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Groups Alcohol Prep Products
    7. AVMA Offers Important Guidance to DEA on New Controls for Induction Agent—Propofol
    8. Activity Against Key Drug-Resistant Pathogens is the Most Important Attribute Influencing Surveyed Physicians Antibiotic Selection for Nosocomial Pneumonia in the U.S.
    9. Cardium Announces New Research Findings: Excellagen Product Candidate Activates Platelet Release of PDGF, an Important Growth Factor Fundamental to the Wound Healing Process
    10. Global Med Technologies(R) Solution of Choice for Important Regional Blood Center
    11. Bend Research Clients May Now Reference Key Safety Document for Important Solubility Excipient
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
    (Date:6/23/2016)... ITASCA, Ill. , June 23, 2016  In a startling ... states are failing their residents by lacking a comprehensive, proven plan ... , a definitive ranking of how states are tackling the ... rating to only four states – Kentucky , ... and Vermont . Of the 28 failing states, ...
    (Date:6/23/2016)... Bracket , a leading clinical trial technology and specialty ... Bracket eCOA (SM) 6.0, at the 52 nd ... in Philadelphia , Pennsylvania.  A demonstration of ... its kind to fully integrate with RTSM, will be held ... a flexible platform for electronic clinical outcomes assessments that is ...
    Breaking Medicine Technology:
    (Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening ... Talker Award, an essay contest in which patients and their families pay tribute to ... at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this ...
    (Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... ... Haute Living, is proud to recognize Dr. Barry M. Weintraub as a prominent ... “the most beautiful women in the world, and the most handsome men, look ...
    (Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
    (Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
    (Date:6/24/2016)... ... June 24, 2016 , ... ... the upcoming 2016 Miss Arizona pageant as its official Medspa Sponsor. Dr. Josh ... Mesa, and Chandler, Arizona. , Dr. Olson says the decision to support ...
    Breaking Medicine News(10 mins):