Just weeks after recalling three lots of 0.9% sodium chloride injection amounting to nearly 600,000 units, Baxter ($BAX) has recalled 8 more lots, adding further to the national shortage of saline. Last time the problem was leaky bags. This time the drugmaker says there is a problem with the chance for particulate in the bags. The FDA also announced the recall in a MedWatch notice.
In addition to the saline, the company is recalling four lots of dextrose and three lots of Lactated Ringer's injection, all of them shipped in the U.S. and Bermuda between January 14 and March 5 this year.
Baxter said the problem was traced back to particulate material from a solution transmission system pump. It said that there have been no adverse reactions reported, but acknowledged that the particulate could cause reactions from an inflammation to something more serious in high-risk patients. The greater problem, of course, is how it affects the national supply of saline.
"Patient safety is Baxter's top priority, and we have issued this recall voluntarily to ensure no product from the affected lots remains in the field," Baxter spokesperson John O'Malley wrote in an email Friday. "Baxter regrets any inconvenience to customers and can assure them that this should have no impact on our efforts to work to meet their needs for IV solutions. We will work directly with customers to address any questions they may have."
There has been a shortage of saline solution for well over a year now. The FDA has been working with Baxter, Hospira ($HSP) and B. Braun Medical to boost their U.S. production to help relieve the situation. It also has allowed imports from three European plants that were not approved to ship saline to the U.S.: a Fresenius Kabi plant in Norway, a Baxter plant in Spain and more recently from a B. Braun plant in Germany. But manufacturing problems have led to more recalls, which has kept the U.S. supply chain from getting fully replenished.
Baxter had two recalls of saline products last year and now two this year. Hospira had to recall two dozen lots of saline solution in the 1000-mL size starting in October. 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.
- read Baxter's announcement
- here's the FDA MedWatch notice