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Ketorolac Tromethamine Injection Recalled by American Regent

American Regent is conducting a voluntary recall on all lots of Ketorolac Tromethamine Injection, NDC# 0517-0601-25 15 mg/mL 1mL Single Dose Vial. This is an extension of a voluntary recall of all unexpired lots initiated in October of 2009.

Ketorolac Tromethamine Injection is a non-steroidal anti-inflammatory drug, NSAID, used to control moderate to severe pain in adults. The voluntary recall comes due to particulates that may be present as a result of crystallization. The company is concerned with the potentially dangerous side effects that may result if a contaminated dose is administered. Some of the dangers include:

Obstructed blood vessels leading to pulmonary embolism or thrombosis
Anaphylactic reactions
Local irritation

To find out how to return or get credit for recalled vials, please contact American Regent at 1-800-645-1706. To report any adverse reactions with the product, email or send a fax to 610-650-7781, 610-650-0170, or call 1-800-734-9236. Adverse reactions should also be reported to the FDA’s MedWatch Adverse Events Reporting program.

If you or someone you love has suffered a negative event related to the use of ketoralac tromethamine injection or another dangerous drug, please contact the product liability attorneys at Schlichter, Bogard & Denton who serve clients nationwide.

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