The FDA is warning healthcare providers that there is a shortage of saline solution, as well as other IV solutions. The agency says it is working with Baxter International ($BAX)--which recently had to recall four lots of saline--Hospira ($HSP) and Braun to boost production.
The FDA said in an announcement posted Friday to its website that it is working with the drugmakers to "help preserve the supply of these necessary products" and boost production. In a letter from Baxter to suppliers posted with the FDA notice, the company said it was working to increase supplies but given that "product supply remains tight," it was forced to put non-contract buyers on an allocations system. "These steps enable Baxter to evaluate and adjust our production levels, provide predictability of demand to our manufacturing plants, establish a timeline for providing additional product; and maintain and improve our service levels for Baxter committed customers," the company wrote.
In December, Baxter had to recall four lots of saline, as well as one lot of 5% dextrose injection, in the U.S. and three other countries after particulate matter was discovered in the solutions. Shortly after, it issued a recall of three lots from its Clinimix line of parenteral nutrition products for the same reason. Hospira recalled a lot of saline in April of last year after a customer found four single particles in a container. The particles ended up being polyester fiber, nylon fiber, cotton fiber and nitrocellulose fiber.
Baxter has had issues with its parenteral manufacturing and last year received an FDA warning letter for plants in Jayuya, Puerto Rico, and Marion, NC. The FDA criticized the plant in North Carolina for not getting to the root of mold problems that led it to stop production on its large-volume parenteral line.
- here's the FDA announcement
- here's the Baxter letter (PDF)