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Contaminiation Issue Prompts American Regent to Recall Injectable Pain Reliever

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Ketorolac Tromethamine Injection USP 30 mg/mL is being recalled by American Regent Inc. because of potential particulate contamination.

According to the recall notice, administering the contaminated Ketorolac Tromethamine Injections could lead to the 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.

On October 16, 2009 America Regent  recalled all unexpired  lots of Ketorolac Tromethamine Injection USP 30 mg/mL  because of possible particulate contamination in conjunction with crystallization.  The firm is now recalling all lots of  the medication as a precaution.  Hospitals, surgi-centers, clinics and other healthcare facilities have been warned not to use any American Regent Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.

The lots involved in this recall include:

NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial
NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.

Ketorolac Tromethamine is an NSAID pain reliever and is approved for use in short-term pain relief of moderate to severe pain. Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. of Shirley, NY.

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