FDA provides update on saline drug shortage
[04/28/2014] In response to the ongoing shortage of 0.9% sodium chloride injection (normal saline),Baxter Healthcare Corp. of Deerfield, Ill., will temporarily distribute normal saline in the United States from its Spain manufacturing facility. FDA is temporarily exercising its discretion regarding the distribution of Baxter’s saline product from Spain and Fresenius Kabi’s saline product from Norway as needed to address this critical shortage, which poses a serious threat to patients.
FDA inspected Baxter’s Spain facility where its normal saline product is made to ensure the facility meets FDA standards. FDA asks that health care professionals contact the Baxter directly to obtain the product.
In addition to these sources of normal saline, U.S.-based manufacturers – Baxter Healthcare Corp. , B.Braun Medical Inc., and Hospira Inc., – are currently producing and releasing normal saline. Baxter’s saline product from Spain will be distributed temporarily in addition to Baxter’s FDA-approved version that is currently manufactured and distributed in the United States.
While the shipments described above will help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection. Preventing drug shortages is a top priority for the FDA, and we are doing everything within our authority to improve access and alleviate this 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.
[01/17/2014] FDA is aware of the shortage situation for intravenous (IV) solutions, particularly 0.9% sodium chloride injection (i.e., saline) used to provide patients with the necessary fluids for hydration and other conditions. The shortage has been triggered by a range of factors including a reported increased demand by hospitals, potentially related to the flu season.
We are working with the three manufacturers of these products, Baxter Healthcare Corp., B.Braun Medical Inc., and Hospira Inc., to help preserve the supply of these necessary products. Addressing this shortage will depend on the increased demand and the manufacturing production of the current suppliers. Millions of these I.V. solutions are used each week by health care professionals.
Please continue to visit the drug shortage webpage for updates. For additional information, customers can also contact the firms directly.
FDA remains committed to doing everything we can to address drug shortages, including finding alternative sources, so that patients can get the medicines they need when they need them.