Voluntary Product Safety Recall

Cardboard Particulate Matter Found in a Sterile Intravenous Infusion Bag

Baxter International has voluntarily recalled one lot of Cefazolin in Dextrose Injection, USP, 2 g/100 mL after a report of cardboard particulate matter was found inside a sterile intravenous infusion bag.

About the Product

Cefazolin is commonly used to treat bacterial infections and to help prevent surgical site infections, making it a widely used injectable antibiotic in hospitals and other healthcare settings.

Affected Lots

The recall affects Lot LD175708 (expiration date February 14, 2027) of the frozen premixed antibiotic, which is supplied in Baxter’s 100 mL GALAXY plastic infusion container. The affected lot was distributed throughout the United States between March 25 and June 30, 2025.

According to Baxter, intravenous administration of particulate-contaminated solutions presents a reasonable probability of serious patient harm.

Potential Complications

Potential complications include pulmonary embolism, blockage of blood vessels, tissue damage, phlebitis, immune system activation, organ dysfunction, and hemolysis. The company said it has not received any reports of adverse events related to the recalled lot.

Instructions to Healthcare Providers and Distributors

Healthcare providers and distributors are advised to immediately discontinue use of the affected lot and follow Baxter’s instructions for returning unused product.

MDP Perspective

Foreign particulate contamination is a well-recognized quality risk for sterile injectable products because anything infused directly into the bloodstream bypasses many of the body’s normal protective barriers. For that reason, sterile manufacturing incorporates multiple layers of environmental controls, filtration, container inspections, and quality assurance measures intended to detect and prevent contamination before products reach patients.

The recall notice identifies the contaminant as cardboard but does not explain how the material entered the finished product. That unanswered question will likely be of particular interest to quality and manufacturing professionals, as determining the source of contamination is a critical part of any root cause investigation and corrective action process.

Although Baxter has characterized this as a single-lot recall and no patient injuries have been reported, the investigation into how cardboard entered a sterile injectable product will be critical.

The findings may confirm an isolated manufacturing anomaly or identify broader process deficiencies that could require additional corrective actions, expanded recalls, or changes to manufacturing controls. For regulatory and quality professionals, the root cause investigation may ultimately prove as important as the recall itself.

Links

Read the FDA Announcement here.