In response to the ongoing shortage of normal saline (0.9% sodium chloride injection), the US Food and Drug Administration (FDA) is allowing a company to import product manufactured in Spain.
Baxter Healthcare Corp. will be allowed to temporarily distribute sodium chloride 0.9% injection solution for intravenous infusion in VIAFLO
non-polyvinyl chloride containers, which is manufactured at the company’s Bieffe Medital, Sabinanigo, Spain facility.
This is the second time in recent months that the FDA has allowed the importation of saline. Last month, the agency announced it would allow Fresenius Kabi USA to import saline products manufactured in Norway.
As with the Norway plant, the FDA has inspected Baxter’s Spain facility to ensure it meets FDA standards.
Baxter will import sodium chloride 0.9% intravenous infusion in VIAFLO containers in the following volumes and quantities: 250 mL (30 bags per carton), 500 mL (20 bags per carton), and 1 L (10 bags per carton).
The FDA is asking that healthcare professionals contact Baxter directly to obtain the product. To place an order, contact Baxter’s Center for Service at 1-888-229-0001.
For more information on the products, see Baxter’s “Dear Healthcare Professional” letter, visit the company’s website, or contact Baxter’s Medical Information Service at 1-800-933-0303.
In addition to the imported saline, US-based manufacturers—B.Braun Medical Inc., Hospira Inc., and Baxter Healthcare Corp.—are producing and releasing normal saline. (Baxter’s saline product from Spain will be distributed in addition to Baxter’s FDA-approved version that is manufactured in the US.)
The FDA noted that, although the aforementioned shipments will help reduce current disruptions, they will not resolve the shortage of 0.9% sodium chloride injection. So the agency will continue working to alleviate the shortage.
