The FDA this week announced that the sodium chloride 0.9% injection product shortages have officially ended.
The products, which are a common form of intravenous (IV) saline, will be removed from the agency’s current shortages list.
The shortage started last year after flooding from the remnants of Hurricane Helene stopped production at Baxter’s North Cove plant in Marion, North Carolina.
Baxter restarted manufacturing operations in November, said production was back to pre-hurricane levels by February, and in May said its inventory levels were fully restored.
FDA Commissioner Marty Makary credited the resolution to collaboration between the agency, the Administration for Strategic Preparedness and Response, and industry partners. Efforts included expanding manufacturing capacity and restoring stability to the supply chain.
“We generally recommend hospitals, health systems, and clinics use the FDA-approved drug when available,” Makary said.
The agency also said it continues to collaborate with manufacturers to address shortages of other IV fluids and will monitor supplies to help ensure patient access. Makary said reliable medical product availability is “essential to patient care and the overall resilience of our healthcare system.”
FDA Commissioner Marty Makary [Photo courtesy of the FDA]
Second shortage resolution this summer
The end of the IV saline shortage follows another removal from the FDA’s shortage list in mid-July. Then, the agency removed intra-aortic balloon and control systems (product code DSP) after supplies stabilized. Those devices were first listed in December 2022.
The FDA also extended the expected shortage end dates for three other device categories — GEI, BYS and DTZ — to the fourth quarter of 2025. Devices still on the list include some electrosurgical cutting and coagulation devices and accessories (GEI), bloodline tubing used in dialysis (FJK), pediatric ventricular assist devices (DSQ), and oxygenator devices for extracorporeal circulation (BYS and DTZ).
The shortage list, required under Section 506J of the Federal Food, Drug and Cosmetic Act, is meant to keep hospitals, physicians and purchasers informed about supply constraints. The presence of a device type on the list does not necessarily mean patient care has been affected, the agency said.
