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# Fresenius Kabi Recalls 1 Lot of Ketorolac Tromethamine
- URL: https://www.fdaweb.com/fresenius-kabi-recalls-1-lot-of-ketorolac-tromethamine/
- Published: 2021-01-11T12:00:00.000Z
- Updated: 2026-09-14T16:42:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148416

Fresenius Kabi USA has recalled one lot of ketorolac tromethamine injection, 30 mg/mL, 1 mL fill in a 2 mL amber vial, due to the presence of particulate matter detected in reserve sample vials. No adverse event reports have been reported with the recalled lot, according to a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp-due-presence?ref=fdaweb.com). “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. A nonsteroidal anti-inflammatory drug, ketorolac tromethamine is indicated for the short-term (up to five) days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.