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American Regent Expands Recall of Injectable Pain Reliever

Oct 21, 2009 | Parker Waichman LLP

American Regent is expanding its recent recall of Ketorolac Tromethamine Injection USP 30 mg/mL.  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.

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.

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.  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)

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.

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

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit."

According to the recall notice, this product  was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

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