FDA Update on Saline Drug Shortage

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 US 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 the Baxter directly to obtain the product.

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 US.

While the shipments described above will help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection.