January 8, 2021

Fresenius Kabi has voluntarily recalled one lot of Ketorolac Tromethamine Injection, USP, 30mg/mL, 1mL fill in a 2mL amber vial. The recall is due to the presence of particulate matter found in reserve sample vials.

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug indicated for short-term management of moderately severe, acute pain that requires analgesia at the opioid level. Use of product containing particulate matter could obstruct blood vessels and cause local irritation of blood vessels, swelling at the injection site, inflamed and/or infected tissue, blood clots that could travel to the lungs, scarring of lung tissue, and potentially life-threatening allergic reactions. As of the date of the recall, Fresenius Kabi has received no reports of adverse events associated with the affected product.

Fresenius Kabi has advised that the recalled product should be quarantined, and its use and distribution should be discontinued. Consumers can direct questions regarding the recall to Fresenius Kabi at 1-866- 716-2459. Patients who have experienced problems that may be related to use of the affected product should contact their healthcare provider. Adverse events can also be reported to the U.S. FDA’s MedWatch program.

The full recall announcement can be found on the FDA’s website.

There is no member impact through Benecard Central Fill.

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