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Thursday, December 17, 2009
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
Granulomas
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 pv@luitpold.com 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.
posted by
Erica
at
2:42 PM
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