American Regent Expands Voluntary Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single ...(ng discussions with the Agency. As is...),Health

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit."

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA's MedWatch Adverse Event Reporting program online, or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

SOURCE Luitpold Pharmaceuticals, Inc.