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:1/19/2017)... NEW YORK , Jan. 19, 2017 /PRNewswire/ ... reach USD 233.7 billion by 2025, according to ... The market is anticipated to be predominantly driven ... companies, resulting into the large-scale production of new ... widen the influx of drugs at an unprecedented ...
    (Date:1/19/2017)... The Global Therapy Partnering Terms and Agreements ... deals and agreements entered into by the world,s leading ... Top deals by value - Deals listed by company ... The report provides understanding and access to the partnering ... healthcare companies. The report provides an analysis of ...
    (Date:1/19/2017)... and Webcast to Follow Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: ... the fourth quarter of 2016 on Wednesday, February 15, 2017, after ... ... on Wednesday, February 15, 2017, during which management will discuss the ... activities. To participate in the conference call, please dial 1-888-771-4371 (domestic) ...
    Breaking Medicine Technology:
    (Date:1/20/2017)... ... January 20, 2017 , ... “Mary Magdalene: Grace is ... life of the woman who witnessed Jesus Christ firsthand. “Mary Magdalene: Grace is Greater ... spent her career as an educator interacting with countless women who had little knowledge ...
    (Date:1/20/2017)... ... 2017 , ... “Code Word: Chocolate Biscuit”: a biographical account following a man who went on ... of published author, Marlyn Ivey, born in Lynn Haven, Florida and at the age of ... 19 years of age, he joined the Navy and got married right out of boot ...
    (Date:1/20/2017)... ... January 20, 2017 , ... D ... Expiratory Pressure (OPEP) device, was featured in a study indicating superior performance against ... FAARC, “Analysis of Three Oscillating Positive Expiratory Pressure Devices During Simulated Breathing“ ...
    (Date:1/20/2017)... ... ... and enchanting tale that teaches children the true meaning of Christmas. “Journey to Christmas” is ... a devoted woman of faith. , “Becoming a parent changes you. In my case, ... for years, but actually doing it might have been a while in coming if it ...
    (Date:1/20/2017)... ... January 20, 2017 , ... “The Land of More ... to the issue of world hunger, and shares the simple and achievable answer. “The ... husband and member of the Fairview Missionary Church in Angola, Indiana where he works ...
    Breaking Medicine News(10 mins):