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Wednesday, January 27, 2021

Fresenius Kabi USA Recalls Ketorolac Tromethamine Injection due to Potential Contamination

Fresenius Kabi USA recalled a single lot of Ketorolac Tromethamine Injection due to potential contamination of particulate matter, posing a potential health risk to consumers.

Fresenius Kabi USA recalled a single lot of Ketorolac Tromethamine Injection due to potential contamination of particulate matter, posing a potential health risk to consumers.

The recalled Ketorolac Tromethamine Injection was distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies.

According to the Food and Drug Administration (FDA), administration of products that contain particulate matter could obstruct blood vessels and could 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 several life-threatening consequences.

Fresenius Kabi has notified its distributors and customers by letter and asked customers and distributors to immediately check their stock and to quarantine and discontinue the use and distribution of the recalled product. 

Distributors will also notify their customers and direct them to the proper steps in handling the recalled product. 

There have been no reported illnesses thus far.

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