FDA MedWatch - Ketorolac Tromethamine Injection USP by Fresenius Kabi: Recall - Due to the Presence of Particulate Matter

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Ketorolac Tromethamine Injection USP by Fresenius Kabi: Recall - Due to the Presence of Particulate Matter AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Fresenius Kabi is voluntarily recalling a single lot of Ketorolac Tromethamine Injection - USP, 30 mg/mL 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. For more information about this recall click on red button "Read Recall" below. BACKGROUND: Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. RECOMMENDATION:  Fresenius Kabi is asking customers and distributors to check their stock immediately and quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing the affected lot, and to return the product to Fresenius Kabi. Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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