Injection Product recall

November 4, 2009 8:22:54 AM PST
American Regent is recalling all lots of Ketorolac Tromethamine Injection, USP, 15 mg/mL, 1mL single dose vial, with the NDC number 0517-0601-25.

The product is used to treat moderate to severe pain after surgical procedures. It is being recalled because it might cause obstruction of blood vessels or blood clots. It could also induce anaphylactic reactions and local irritation at the injection site and present other risks.

No incidents or injuries have been reported to the company. The company said the product was distributed mainly to hospitals, clinics and health care facilities, however consumers might have been able to purchase the product with a prescription at a pharmacy.

For more information,consumers can call 800-645-1706. Adverse reactions can be reported to the Food and Drug Administration at http://www.fda.gov/medwatch/report.htm.

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