Drug Safety Alerts

Baxter IV Products Class I Recall

06/01/2016


On June 1, 2016, the United States Food and Drug Administration (FDA) issued a Class I Recall on various intravenous (IV) solutions manufactured by Baxter Healthcare Corporation. This recall was issued due to the potential for leaking containers and particulate matter. Leaking containers could result in contamination of the solution. If not detected, this could lead to a bloodstream infection, worsened patient condition or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack, damage to other organs such as kidney or liver, or death. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

This recall was originally issued to the hospital/user-level on January 25, 2016. The FDA classified this recall as a Class I Recall on June 1, 2016.

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

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information on this recall, health care providers may contact Baxter Healthcare Center for Service 1‑800‑422‑9837, Monday through Friday, 7:00 am to 5:00 pm (CT). You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.