March 24, 2020

Fresenius Kabi USA has issued a voluntary recall of 13 lots of Ketorolac Tromethamine Injection, USP, 30mg/mL, 1mL fill in 2mL amber vials and Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg/mL), 2mL fill in 2mL amber vials due to the presence of particulate matter. The particulates are composed of carbon, silicon, oxygen, and polyamides (a type of synthetic polymer).

Patients who receive an injection of ketorolac tromethamine containing the particulate matter could be at risk of blood vessel obstruction, local irritation of blood vessels, swelling at the site of injection, development of a tissue mass that could become inflamed and infected, blood clots traveling to the lung, scarring of lung tissues, and allergic reactions. These adverse events could be life-threatening.

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) indicated to provide short-term management of moderately severe acute pain that requires opioid level analgesia. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine should not exceed five days. The injection dosage form is typically administered by a qualified healthcare professional in a clinical setting such as a hospital or doctor’s office.

Fresenius Kabi has asked distributors and healthcare providers to return any recalled product in their possession and halt any further distribution or use product from the recalled lots. Patients should contact their healthcare provider if they experience any issues that may be related to the administration of the product. In addition, adverse events can be reported to the U.S. FDA’s MedWatch program. Questions regarding the recall should be directed to Fresenius Kabi at 1-866-716-2459.

Further information, including lot numbers of the recalled product, can be found at the FDA’s website.

There is no member impact through Benecard Central Fill.

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