Recalls That Should Be on Your Radar—Week of March 1, 2020

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Hikma Pharmaceuticals USA Extends Recall of Ketorolac Tromethamine Injection Vials Due to Possible Presence of Small Particulates

Hikma Pharmaceuticals is voluntarily extending a previously announced recall of certain lots of Ketorolac Tomethamine Injection USP 30mg/mL, 1mL fill/2mL vials. Small visible particulate matters of a gelatinous or oily nature have been found in some of the recalled lots.

The recall was initiated on December 23, 2019. The recall has been extended to the medical facility and recall levels.

Use of the impacted product could result in particulates entering the lungs of patients, which could lead to multiple pulmonary microemboli with subsequent acute respiratory distress.

There have not been any adverse reports to date.

Read the recall statement.

Becton Dickinson CareFusion 303 Issues Recall of Alaris System Infusion Pumps Due to Software and Symptom Errors

Becton Dickinson CareFusion 303 has issued a recall of the Alaris System infusion pump system and modules due to multiple system errors, use-related errors, and software errors.

Modules running on software version 9.33 or earlier may have low battery alarm failures, issues with delay options programming, and use related errors related to custom concentration programming.

Modules running on software version 12.1.0 may have low battery alarm failures, use related errors related to custom concentration programming, and the KVO rate not being available when using delay options programming.

The errors can lead to interruptions or delays in infusion as well as slower or faster delivery of medication than intended. There have been serious health adverse events. One death and 55 injuries have been reported.

Read the recall statement.