Recall report: Fresenius Kabi yanks inflammatory med Ketorolac after finding particulates in vials
The FDA on Friday announced that Fresenius Kabi USA, based in Illinois, voluntarily recalled a single lot of Ketorolac Tromethamine Injection USP 30 mg/mL. Particulate matter was found in reserve sample vials of the drug, which is used as a short-term medication to manage severe acute pain which requires analgesia at the opioid level.
Fresenius Kabi USA has received no reports of negative side effects from the lot, the FDA said in a release.
Administering products that contain particulate matter could obstruct blood vessels and result in local irritation of blood vessels, or result in swelling at the site of injection, the FDA said. Tissue mass could also become inflamed and infected, blood clots could travel to the lung, lung tissues could scar, and patients could have life-threatening allergic reactions.
The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine Injection should not exceed five days, the FDA said.
The NDC number of the recalled lot is 63323-162-01, and the batch number is 6121083. The product is scheduled to expire in February.
The recall is the second Fresenius Kabi USA has had to issue in the past two months. In November, the company pulled back one lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial due to a trace amount of lidocaine present. The lidocaine could’ve been potentially harmful to surgical patients with a lidocaine allergy, the FDA said at the time.