Fresenius Kabi announced a voluntary recall of 13 lots of Ketorolac Tromethamine Injection 30mg/mL and 60mg/2 mL vials due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in 8 reserve sample vials.
The 13 recalled lots of Ketorolac Tromethamine Injection, 30mg/mL (NDC 63323-162-01) and 60mg/2 mL (NDC 63323-162-02), were distributed to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019. A complete list of the recalled products, including expiration dates, lot numbers and distribution dates, can be found here.
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 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.
Adverse reactions may 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.