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American Regent Expands Voluntary Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials
Date:11/3/2009

SHIRLEY, N.Y., Nov. 3 /PRNewswire/ -- American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL:

            NDC# 0517-0601-25     15 mg/mL       1mL Single Dose Vial

PLEASE NOTE: This recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization.

This voluntary recall is due to the potential that particulates from crystallization may be present in the product. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 15 mg/mL for patient care and should immediately quarantine any product for return.

"Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks as we continue to investigate this issue," 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 ongoi
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SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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