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FDA provides update on saline drug shortage

Monday, April 28, 2014 8:03 PM | PAAW Administrator (Administrator)
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 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.

 

The Professional Ambulance Association continues to report and share information as it becomes available.  To review Bound Tree Medical's weekly pharmaceutical backorder report, click here.
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