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American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, Lot # 0048 Due to Translucent Visible Particles
Date:2/3/2011

7781or (610)650-0170oryhonea1-800-734-9236.  TOEXPEDITE HANDLINGPLEASE DONOT REPO ANYTHINGOTHETHANSPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX O PHONE.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

  • "All of us at American Regent and Luitpold are taking the necessary steps to protect patients from any potential safety risks with our Potassium Phosphates Injection. The safety and well being of patients receiving our products is our primary concern," said Mary Jane Helenek, President and CEO of American Regent.

    While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall.  American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

    As is standard practice, and as stated in the Potassium Phosphates Injection, USP, Product Package Insert, "Parenteral drug products should b
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    SOURCE Luitpold Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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