IV Fluid Shortage Update
As North Carolinians continue to recover from Hurricane Helene, hospitals across the US are being impacted by an IV fluid shortage caused by the devastation to Baxter’s North Cove manufacturing site in Western NC. Baxter International is one of the largest suppliers of IV fluids in the United States, with its North Cove facility providing 60 percent of the country’s IV fluid, according to the American Hospital Association.
The plant has been closed for weeks due to the damage triggered by Hurricane Helene, which has led to hospitals implementing conservation efforts and cancelling some elective procedures to conserve critical supplies. Hospitals welcomed news from Baxter this week that it is now authorized by the Food and Drug Administration (FDA) to extend the use date of some products to provide a 24-month expiration from the manufacture date without relabeling the products.
In a letter to customers, Baxter said the extended expiration date is based on Baxter’s submission to the FDA including container closure integrity data, container functional performance data, and an analysis of product weight loss profiles for those certain product codes. Please see the Baxter document that contains the full list of Baxter product codes, lot/serial numbers, labeled expiration dates, and extended expiration dates. The extended expiration dates apply only to product codes manufactured prior to Sept. 30, 2024.
In addition, Baxter announced more important updates this week:
- All 2,500+ Baxter North Cove employees have been accounted for following Hurricane Helene. Employees are returning to work at pre-hurricane staffing levels, working alongside remediation contractors that have been engaged on a temporary basis for site recovery.
- Rapid progress in restoring the physical facilities has exceeded expectations. Their first temporary bridge has already transported more than 825 truckloads of finished product off site and to customers.
Baxter’s goal remains to begin resuming North Cove production as soon as possible and in phases by the end of this year. Baxter anticipates restarting the highest-throughput IV solutions manufacturing line this week. Initial batches will be manufactured concurrently with ongoing quality activities and would only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products. It is important to note that the earliest that new North Cove product could begin entering the distribution channel is mid- to late-November. Currently Baxter has no timeline for when its North Cove production will be fully restored to pre-hurricane levels.
For the latest information and updates, visit Baxter.com.