Drug Safety Alerts

Ketorolac Tromethamine Injection Class I Recall

6/17/2020

On June 17, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of Ketorolac Tromethamine 30 mg/1 mL Injection, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01), manufactured by Fresenius Kabi. This recall was issued because particulate matter was found in reserve sample vials at the firm.

A complete list of the affected products and lot numbers is provided here.

According to Fresenius, 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.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short term (up to 5 days in adults) management of moderately severe acute pain.

Please note: This recall was issued to the hospital/user-level on April 20, 2020. On June 17, 2020 Enforcement Report, FDA identified this as a Class I recall.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using this product to contact their prescriber.

For more information about the [action taken], please call Fresenius Kabi toll-free at 1-866-716-2459 Monday through Friday, 8:00 am to 5:00 pm (CT). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.