Recall of Injectable Painkiller Expanded by American RegentNov 4, 2009 | Parker Waichman LLP
American Regent is recalling more Ketorolac Tromethamine Injection. The company is now expanding its recall of the injectable painkiller to include all lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials; NDC# 0517-0601-25.
According to the Food & Drug Administration (FDA), this recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. The recalled drug product was distributed to wholesalers and distributors nationwide.
The recall has been put in place over the potential that particulates from crystallization may be present in the product. Safety issues, if the product is administered to patients, could include obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets, and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.
Hospitals, surgi-centers, clinics, and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 15 mg/mL for patient care and should immediately quarantine any product for return. 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. Questions about the return process should be made to American Regent’s Customer Service department toll-free at 1-800-645-1706: Monday through Friday from 8:30 AM to 7:00 PM Eastern Time. Hospitals, surgi-centers, clinics, and healthcare providers, or patients with other questions may contact the Professional Services Department at 1-631-924-4000, said the FDA.
Adverse reactions and/or quality problems should be reported to American Regent, Inc. via email to PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170, or by phone, toll-free, to 1-800-734-9236. Adverse reactions should be reported to the FDA's MedWatch Adverse Event Reporting program online; by returning the postage paid FDA form 3500, by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; or via fax, toll-free to 1-800-FDA-0178.
Last month we wrote that American Regent expanded its-then recent recall of Ketorolac Tromethamine Injection USP 30 mg/mL. Just prior, On October 16, America Regent recalled all unexpired lots of Ketorolac Tromethamine Injection USP 30 mg/mL because of possible particulate contamination in conjunction with crystallization. The lots involved in that recall include: NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)
Ketorolac Tromethamine is an NSAID pain reliever approved for use in short-term pain relief of moderate to severe pain. Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. of Shirley, New York.