FDA Extends IV Fluid Expiry Dates After Shortage Due to Hurricane Helene

File photograph shows bottles of fluid used for intravenous therapy in the emergency room of a hospital in Marseille, France, on Jan. 11, 2017. Boris Horvat/AFP via Getty Images

Baxter International, the leading supplier of intravenous (IV) solutions to hospitals in the United States, said on Oct. 28 that it received approval from the Food and Drug Administration (FDA) to extend the expiry dates of its products.

Baxter temporarily shut down its North Cove manufacturing plant in North Carolina on Sept. 29 due to the impact of Hurricane Helene, which led to a shortage in the supply of IV fluids.

The FDA has allowed a 24-month expiry period for over 50 IV and irrigation products, doubling the standard one-year shelf life, Baxter said in a statement.

The changes apply to products manufactured before September 2024. The company said that it has communicated the expiry date extension details to its customers.

The plant accounts for 60 percent of the IV fluids used in the United States, and produces roughly 1.5 million bags of IV solutions per day, according to the American Hospital Association (AHA).

Earlier this month, a spokesperson for the U.S. Department of Health and Human Services (HHS) told The Epoch Times that it invoked the Defense Production Act of 1950 to “help Baxter obtain materials needed to clean and rebuild the facility.”

In Monday’s statement, Baxter said that it could not provide a specific timeline for the complete restoration of the North Cove plant, but that it aims to resume the plant’s operations in phases by the end of the year.

“We are encouraged to report that, barring any unanticipated developments, Baxter anticipates restarting the highest-throughput IV solutions manufacturing line this week,” the company said. “It is important to note that the earliest that new North Cove product could begin entering the distribution channel is mid- to late-November.”

Baxter said that it has transported more than 825 truckloads of finished products to its customers using a temporary bridge at the North Cove plant and activated nine plants across its global network to increase inventory.

A second temporary bridge is being constructed near the plant to allow more truck and equipment traffic to enter and leave the site.

It is expected to be completed in early November.

“Conservation efforts for IV and PD [peritoneal dialysis] solutions across the healthcare system remain essential to supplement allocation levels and help preserve supply, and we are grateful for our customers’ efforts in this area,” Baxter stated.

The AHA, which represents nearly 5,000 member hospitals and 43,000 health care leaders, had previously urged the federal government to declare a national emergency due to a shortage of IV solutions.

In an Oct. 7 letter, the association urged the federal government to identify international manufacturers capable of producing IV fluids and extend the shelf-life of all IV solutions that are “beyond or nearing their expiration date.”

The U.S. Centers for Disease Control and Prevention (CDC) issued a health advisory on Oct. 12 to warn health care providers and pharmacists about a supply disruption of peritoneal dialysis and IV solutions. The advisory included recommendations on ways to optimize the use of IV solutions and conserve supplies.

Naveen Athrappully contributed to the report.