FDA Allows Imported Saline to Address Shortage

Mar 31, 2014
By PharmTech Editors

p>FDA has announced on March 28 that due to an ongoing 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 says it 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 reports that it inspected Fresenius Kabi’s Norway facility where its normal saline product is made to ensure the facility meets FDA standards. While these initial shipments will help, they will not resolve the shortage, according to a FDA report.

The agency says it is working closely with manufacturers to meet the needs for normal saline across the US in the coming weeks and it 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.

Source: FDA