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| United States: Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter (English only) |
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The United States Food and Drug Administration (FDA) announces that Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial (batch number: 6121083) to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp-due-presence
In Hong Kong, Ketorolac Kabi Solution for Injection 30mg/mL is registered by Fresenius Kabi Hong Kong Limited (Fresenius Kabi) and is a prescription-only medicine. As confirmed with Fresenius Kabi, the affected batch has not been imported into Hong Kong.
Ends/Saturday, Jan 09, 2021
Issued at HKT 14:30
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