To help address a shortage of saline used in dialysis clinics and hospitals, the U.S. Food and Drug Administration said that it would allow Fresenius Kabi USA, LLC to temporarily distribute normal saline in the United States from its Norway manufacturing facility.
The FDA said it inspected Fresenius Kabi’s Norway facility where its normal saline product is made to ensure the facility meets FDA standards. Health care professionals should contact Fresenius Kabi USA directly to obtain the product, the FDA said.
"While these initial shipments will help, they will not resolve the shortage," the FDA said in a notice on its website. "However, FDA is working closely with manufacturers to meet the needs for normal saline across the U.S. in the coming weeks."
The agency said it would continue to work with Baxter Healthcare Corp., B.Braun Medical Inc., and Hospira Inc. as they seek to restore their supply of normal saline for U.S. hospitals and health clinics. The FDA also said it is working with Fresenius Medical Care, which supplies normal saline to dialysis centers.
The National Renal Administrators Association sent a letter to the U.S. Food and Drug Administration in September, encouraging them to help make sure the matter is resolved safely and expeditiously.