FDA OKs Normal Saline from Baxter's Spanish Facility

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-30-2014 10:42

FDA has reported that in response to the ongoing shortage of 0.9% sodium chloride injection (normal saline), Baxter Healthcare Corp. will temporarily distribute normal saline in the United States from its manufacturing facility in Spain. 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 the shortage of this drug.

In addition to these sources of normal saline, US-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. FDA inspected Baxter’s Spain facility where its normal saline product is made to ensure the facility meets FDA standards.

"While the shipments described above will help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection," said FDA in a statement. "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."

FDA had provided Fresenius Kabi to provide saline product from its manufacturing facility in Norway in late March to address the shortage.

Source: FDA


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