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FDA Update on the Shortage of Normal Saline

Friday, March 28, 2014

On March 28, the Food and Drug Administration (FDA) provided ASA an update on the shortage of Normal Saline:

“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.”

FDA’s general web posting on the shortage:  http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314743.htm

Dear Healthcare Professional letter:  http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM390949.pdf

Labeling:  http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM390952.pdf

FDA update on Saline drug shortage:  http://www.fda.gov/Drugs/DrugSafety/ucm382255.htm

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