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# Fresenius Kabi Recalls Ketorolac Tromethamine
- URL: https://www.fdaweb.com/fresenius-kabi-recalls-ketorolac-tromethamine/
- Published: 2020-04-20T12:00:00.000Z
- Updated: 2026-09-14T16:11:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146606

Fresenius Kabi has recalled 13 lots of ketorolac tromethamine injection, 30 mg/ml, and ketorolac tromethamine injection 60 mg/2 ml due to the presence of particulate matter, which was identified as carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials, a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-13-lots-ketorolac-tromethamine-injection-usp-due?utm%5Fcampaign=Ketorolac%20Tromethamine%20Injection&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. “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. The nonsteroidal anti-inflammatory drug is indicated for the short-term management of moderately severe acute pain.