Saturday, 18 December 2010

Baxter Recalls Peritoneal Dialysis Solutions

This only applies to European supplies, according to an update.

A Reuters article reported the following news, on 17 December 2010.

Baxter has recalled the following products, due to the potential presence of endotoxins - Dianeal, Extraneal and Nutrineal. According to a spokesperson of the European Medicines Agency "Although the number of batches affected is likely to be low, the agency's Committee for Medicinal Products for Human Use has concluded that current stocks should be replaced, because it is not possible to identify which bags are affected."

There is a risk that patients who receive solutions containing endotoxins may develop aseptic peritonitis. The toxins are thought to have been caused by bateria settling on microscopic cracks in two tanks used in the production of these solutions, at their Irish factory in Castlebar.