There has been another glitch in the supply of saline in the U.S., with a manufacturing problem leading Baxter ($BAX) to another recall, this time of nearly 600,000 units. Manufacturing problems by all the major producers have resulted in a shortage that has gone on for well over a year now, leading hospitals to rethink their use of a product they once took for granted.
According to the FDA's most recent Enforcement Report, Baxter last month voluntarily began recalling 597,498 units of 0.9% sodium chloride injection, 500 mL in its Viaflex plastic containers. The recall came after the company received complaints that some of the containers were missing closures and leaked, leaving questions about the sterility of the product.
"Baxter regrets any inconvenience to customers and can assure them that this should have no impact on our efforts to work to meet their needs for saline," Baxter spokesperson John O'Malley said in an emailed response. "We will work directly with customers to address any questions they may have. The root cause of this particular issue has been identified and corrective actions are in process."
The FDA has been scrambling to help hospitals maintain saline supplies. It has been working with Hospira ($HSP), Baxter and B. Braun Medical to boost their U.S. production, while also turning to imports from two European plants that were not approved to ship saline to the U.S., a Fresenius Kabi plant in Norway and a Baxter plant in Spain. But even as drugmakers have responded with added production, manufacturing glitches have continued, keeping the solution on the FDA's drug shortages list.
Baxter had two recalls of saline products last year while Hospira had to recall two dozen lots of saline solution in the 1000-mL size starting in October, also because of issues with leaking bags. According to the FDA Shortages list, Hospira, Baxter, B. Braun Medical and two units of Fresenius all have some product available, although in some cases it is being allocated and reserved for existing customers.
- here's the Enforcement Report notice