Fresenius Kabi announced the voluntary recall of a single lot of Ketorolac Tromethamine Injection, USP, 30mg/mL, 1 mL fill in a 2 mL amber vial due to the presence of particulate matter.

Ketorolac tromethamine injection, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. According to Fresenius Kabi, “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.”

The recalled lot of Ketorolac Tromethamine Injection, 30mg/mL (NDC 63323-162-01) includes:

  • Batch Number 6121083; Expiration Date 02/2021; Distributed between 3/28/2019 and 9/3/2019.

The Company is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately. Any recalled product should be discontinued from distribution or dispensing and returned to Fresenius Kabi. The recall letter and response form are available here.


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Adverse reactions related to this recall should be reported to the FDA’s MedWatch program.

For more information regarding this recall, contact Fresenius Kabi at (866) 716-2459 or visit fresenius-kabi.com.

Reference

Fresenius Kabi issues voluntary nationwide recall of ketorolac tromethamine injection, USP due to the presence of particulate matter. [press release]. Lake Zurich, IL: Fresenius Kabi, USA; January 8, 2021.