Medicine recalls
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| Australia: Recall: Dianeal peritoneal dialysis solution and various irrigation solutions - risk of adverse events due to potential dilution |
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Consumers and health professionals are advised that Baxter Healthcare, in consultation with the TGA, has initiated a recall of certain batches of Dianeal peritoneal dialysis solution and various irrigation solutions due to the potential that these products may have been diluted with water for injection during manufacture. Details of the batch numbers involved can be found in the TGA's website.
Dianeal peritoneal dialysis solutions are used during peritoneal dialysis, a process that removes toxins and waste products from the bodies of people with kidney disease. The solution can be used in hospitals and by patients for self-treatment in their homes. Irrigation solutions can be for various purposes, including during surgical procedures to cleanse tissue.
Following an investigation into the hospitalisation of a patient with serious hyponatraemia after using a 6 litre Dianeal peritoneal dialysis solution, it was found that some bags of solution from the same batch had been diluted and did not contain the correct levels of active ingredients. The batch, numbered S87W2, was recalled and Baxter Healthcare provided hospitals and patients further information and alternative products. Further investigation by Baxter Healthcare has identified additional batches of Dianeal peritoneal dialysis solution and various irrigation solutions that were manufactured in the same facility, using the same manufacturing process, which could potentially be affected by the dilution error. As a precaution, Baxter Healthcare has extended the initial recall to all potentially affected products and is contacting hospitals and patients to provide further information and alternative products.
The TGA is continuing to work with Baxter Healthcare to address the root cause of the problem and ensure appropriate corrective actions are implemented. Manufacturing has been suspended until these corrective actions have been completed. As of 9 April 2015, there have been no other reports of patients experiencing problems as a result of this issue.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/dianeal-peritoneal-dialysis-solution-and-various-irrigation-solutions
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Saturday, April 11, 2015
Issued at HKT 12:00
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