The FDA has put an import alert on saline solution coming out of a Baxter International ($BAX) plant in Canada after someone apparently tried to cross the border with some of the product . The U.S. is suffering through a shortage of saline but Baxter and the FDA made clear that the import alert was not connected and would not affect that situation.
According to the import alert, Baxter's plant in Mississauga, in Ontario, is now prevented from shipping sodium chloride, or saline solution, as well as potassic saline. While there is a shortage of saline in the U.S. Baxter and the FDA said that this situation will in no way affect that.
In a statement emailed from a Baxter spokesman, the company said the saline solution produced at Baxter's facility in Canada is not approved for use in or imported by Baxter to the U.S., "therefore we would not anticipate any impact to Baxter's saline supply in the U.S." He said Baxter is talking with the FDA to understand what precipitated the ban but it appeared to be related to "an individual bringing a small quantity across the border for personal use."
The FDA on Weddnesday said in an email, "We do not anticipate that the recent import alert issued on April 10, 2014 involving 0.9% sodium chloride (saline) will impact availability of this drug. FDA is continuing to work with the manufacturers to address the shortage and new information will continue to be posted as soon as it is available on the FDA website." The agency could not provide any details about what events had led to the import alert.
The FDA has been scrambling for months to help relieve shortages of some common products used in U.S. hospitals, including saline solution and nitroglycerin. It has been working with Baxter, Hospira and B.Braun Medical to boost production of saline, a product that hospitals use by the millions of units a week. It also has been looking outside the U.S. for extra supplies. Late last month, the agency said it would temporarily allow German drugmaker Fresenius Kabi to bring in saline solution made at a plant in Norway that is not currently approved to ship the product to the U.S. While this will help, the FDA acknowledged it "will not resolve the shortage."
Baxter has been the one continuous supplier of saline solutions to the U.S. market in the face of increased customer demand and decreased availability from other suppliers. "We are producing at maximum capacity to meet patient and customer needs. We increased production 3% in 2013 year over year, and are investing to increase production another 9% in 2014," Baxter said in an email.
- find the alert here