American Regent Recalls All 30-mg/mL Ketorolac Vials

Cheryl A. Thompson

BETHESDA, MD 21 October 2009—American Regent Inc. on October 16 recalled all lots of the company's 30-mg/mL ketorolac tromethamine injection because of the presence of "particulate matter in conjunction with crystallization," according to a press release circulated today by FDA.

The recall affects 1- and 2-mL vials of ketorolac tromethamine injection 30 mg/mL but not the 15-mg/mL product.

American Regent said hospitals, surgical centers, clinics, and other health care facilities should not use any of the company's 30-mg/mL ketorolac tromethamine injection for patient care and should immediately quarantine all of that product for return.

The company said it will credit accounts for all vials returned because of the recall.

Questions about the return process should be directed to the customer service department at 800-645-1706, available 8:30 a.m. to 7 p.m. ET Monday through Friday. Other questions should be directed to the professional services department at 631-924-4000.

Quality problems and adverse reactions during the use of this product should be reported to the company via e-mail at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170, or by telephone at 800-734-9236. Adverse reactions may also be reported to FDA's MedWatch program online, by telephone at 800-FDA-1088, or via postage-paid Form FDA 3500 (PDF).

FDA-approved labeling for injectable ketorolac states that the nonsteroidal antiinflammatory drug is used for the short-term management of acute pain that is moderately severe and requires analgesia at the "opioid level," usually in a postoperative setting.

American Regent, a subsidiary of Luitpold Pharmaceuticals Inc., distributes 15- and 30-mg/mL ketorolac products. Luitpold manufactures the products and is a wholly owned subsidiary of Daiichi Sankyo Co. Ltd.