SHIRLEY, N.Y., Nov. 3 /PRNewswire/ -- American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL:
PLEASE NOTE: This recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization.
The product was distributed to wholesalers and distributors nationwide.
“Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks as we continue to investigate this issue,” said Mary Jane Helenek, President and CEO of American Regent.
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.”
Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.
Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
Luitpold Pharmaceuticals, Inc.
