Fresenius Kabi is recalling one lot of its drug ketorolac after finding particulate matter in some of the vials.
Ketorolac is a nonsteroidal anti-inflammatory drug used to manage moderately severe acute pain in adults.
The FDA said Jan. 8 that giving patients an injectable drug that contains particulate matter could obstruct blood vessels, resulting in local irritation of blood vessels, injection-site swelling, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of lung tissues and allergic reactions that could lead to life-threatening consequences.
No adverse events have been reported to the drugmaker.
Fresenius Kabi, based in Germany, is asking its customers and distributors to check their stocks and quarantine and discontinue use of the affected drugs.
Find the full news release here.
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