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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

NOT USE IF PARTICULATES ARE PRESENT.  USE A NEW VIAL.
  • Use a 5 micron filter needle to withdraw the required calculated volume of Potassium Phosphates Injection, USP.
  • 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.
  • Visually inspect the final IV admixture solution.  DO NOT USE IF PARTICULATES ARE VISIBLE.  USE A NEW VIAL.
  • Use a 0.22 micron in-line filter when administering the final IV admixture to patients.
  • 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'/>"/>

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

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