FDA Provides Update on Saline Drug Shortage

[03/28/2014] Due to the shortage of 0.9% sodium chloride injection (normal saline) Fresenius Kabi USA, LLC of Lake Zurich, Ill., will temporarily distribute normal saline in the United States from its Norway manufacturing facility. FDA is temporarily exercising enforcement discretion for the distribution of Fresenius Kabi USA’s normal saline product while it is needed to address this critical shortage that directly impacts patients.

FDA inspected Fresenius Kabi’s Norway facility where its normal saline product is made to ensure the facility meets FDA standards. FDA asks that health care professionals contact the Fresenius Kabi USA directly to obtain the product.

Hospitals and health clinics nationwide rely on normal saline to treat patients with hydration and other medical needs.

While these initial shipments will help, they will not resolve the shortage. However, FDA is working closely with manufacturers to meet the needs for normal saline across the U.S. in the coming weeks.

FDA will continue working 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. In addition, FDA is working with Fresenius Medical Care, which supplies normal saline to dialysis centers.

FDA remains committed to doing everything it can to address this shortage. While FDA cannot require a manufacturer to produce a product, the agency will continue to use all the tools at its disposal to mitigate this and other drug shortages.