American Regent Recalls All Ketorolac Vials

Cheryl A. Thompson

BETHESDA, MD 04 November 2009—American Regent Inc. on November 3 announced a recall of all of the company's 15-mg/mL ketorolac tromethamine injection for the same reason it recalled all 30-mg/mL vials in mid-October: "the potential that particulates from crystallization may be present."

The cause is still under investigation, the company said.

American Regent said health care facilities should not use any of the company's ketorolac tromethamine injection for patient care and should immediately quarantine any product for return and credit.

The company is a subsidiary of Luitpold Pharmaceuticals Inc., which manufactured the product and is a wholly owned subsidiary of Daiichi Sankyo Co. Ltd.

According to FDA databases, nine other companies make 15- and 30-mg/mL ketorolac tromethamine injection.