The move, detailed in a letter to the EMA, follows Baxter’s warning last month that a small number of its Dianeal, Extraneal and Nutrineal products made at the facility may contain endotoxins that could elicit adverse reactions in dialysis patients.
The US firm, which was unable to recall the products due to a lack of any replacement, told the European Medicines Agency (EMA) it has not yet solved the problem and has halted production to begin replacing majority of manufacturing components.
In response the EMA said its Committee for Medicinal Products for Human Use (CHMP) has started a full review of manufacturing operations at Castlebar.
“There is a risk that patients who receive PD solutions that contain endotoxins may develop aseptic peritonitis. However the number of PD bags affected is likely to be very small and the overall risk to patients remains low.”
The agency also said that while remaining stocks will continue to be shipped from the plant, the CHMP has cleared Baxter to import suppliers from its other plants in Canada, Singapore, Turkey and the US to make up for the shortfall.
Baxter spokeswoman Erin Gardiner confirmed that manufacturing operations on the affected line had halted and told the Wall Street Journal that: "Our root-cause investigations and remediation efforts continue.”
The firm, which is due to report its fourth-quarter results on Thursday, did not respond to in-PharmaTechnologist.com’s request for additional information.
According to its results for the first nine months of 2010, Baxter’s peritoneal dialysis business, which is part of the renal products unit it set up in 2010, generated revenues of nearly $9.34bn, equivalent to 15 per cent of earnings to that point.