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FDA Updates information Regarding Saline Shortages

Apr 03, 2014

Due to the shortage of Normal Saline, Fresenius Kabi USA LLC, 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. 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. Please find below the links to the updated general web posting, the Dear Healthcare Professional letter, labeling and an update on this new supply.
o http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314743.htm
o http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM390949.pdf
o http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM390952.pdf
o http://www.fda.gov/Drugs/DrugSafety/ucm382255.htm