Drug Safety Alerts

Ketorolac Tromethamine 30 mg/1 mL Injection Class I Recall

2/03/2021

On February 3, 2021, 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 63323-0162-01); 25 x 1 mL Single Dose Vials per tray (NDC 63323-0162-00), manufactured by Fresenius Kabi. This recall was issued because particulate matter was found in reserve sample vials at the firm.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

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

According to Fresenius, administration of products containing particulate matter could lead to several health risks, such as obstructed and local irritation of blood vessels, injection site swelling, inflamed and infected tissue mass, blood clots that could travel to the lung, scarring of lung tissues, and allergic reactions with possible 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 user-level on December 18, 2020. On the February 3, 2021 Enforcement Report, the FDA identified this as a Class I recall.

CVS Caremark Response: Because of this action, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service Pharmacy and their physicians.

For more information, call Fresenius Kabi toll-free at 1-866-716-2459 Monday through Friday, 8:00 AM to 5:00 PM (CST). You may also call the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.