Ketorolac Tromethamine Injection Recall Issued Due to Contamination
Published: October 22nd, 2009 • No Comments
The FDA posted a recall notice Wednesday from American Regent, indicating that all lots of Ketorolac Tromethamine, USP 30 mg/mL injections are being recalled due to the risk that they may be contaminated. This poses a serious risk for potentially life-threatening injuries, including blood clots, pulmonary embolism or anaphylactic reactions in some patients.
The Ketorolac Tromethamine Injection recall was issued after the manufacturer discovered that some of the vials contained particulate matter due to crystallization. According to American Regent, no injuries or deaths have been reported in conjunction with the contaminated drugs.
Ketorolac Tromethamine is the generic version of Toradol and Acular. It is a prescription non-steroidal anti-inflammatory drug (NSAID) also used as a pain killer and fever reducer. The generic being recalled is manufactured by Luitpold Pharmaceuticals, Inc., and distributed by American Regent, Inc.
“American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions,” according to the press release issued by the company. “Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.”
The package insert for the drug already warns that the vials should be inspected visually for particulate matter and discoloration before administering the drug, when possible. However, given the safety risk, American Regent issued a recall and will credit accounts for all returned Ketorolac Tromethamine Injection products.
The recalled drugs include all lots of American Regent’s Ketorolac Tromethamine Injection, USP 30 mg/mL; NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial, and NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL). The recall does not include the 15 mg/mL injections. The contaminated drugs were sold to hospitals, clinics and other healthcare facilities nationwide.
Anyone with the recalled drugs should contact American Regent’s customer service department at 1-800-645-1706 to return the drugs and have their account credited for a full refund. Any adverse reactions should be reported to FDA’s MedWatch program.
