Fresenius Kabi Recalls 1 Lot of Ketorolac Tromethamine

Fresenius Kabi USA has recalled one lot of ketorolac tromethamine injection, 30 mg/mL, 1 mL fill in a 2 mL amber vial, due to the presence of particulate matter detected in reserve sample vials. No adverse event reports have been reported with the recalled lot, according to a recall notice. “Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences,” it says. A nonsteroidal anti-inflammatory drug, ketorolac tromethamine is indicated for the short-term (up to five) days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.