Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection

The US Food and Drug Administration (FDA) has announced that Fresenius Kabi, LLC is voluntarily recalling 13 lots of ketorolac tromethamine injection, USP, 30mg/mL, 1mL fill in a 2mL amber vial and ketorolac tromethamine injection, USP, 60mg/2mL (30mg/mL), 2mL fill in a 2mL amber vial to the user level. 

According to the regulatory body, the recall is being conducted due to the presence of particulate matter composed of carbon, silicon, oxygen and polyamides, which was found in eight reserve sample vials.

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 travelling to the lung, scarring of the lung tissues and allergic reactions that could lead to life-threatening consequences.

Ketorolac tromethamine, a non-steroidal anti-inflammatory drug, 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. 

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to 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 any affected lots and to return the product to the company.

The list of lots in the recall can be found here.