2 Apr 2009
A spokesman for the Department of Health said today (April 2) that Fresenius Medical Care Hong Kong Ltd, a licensed importer of pharmaceutical products, had initiated a voluntary recall of two batches of Continuous Ambulatory Peritoneal Dialysis Solutions (CAPD).
The two batches of product (batch numbers PCB011 and PHB212), comprising 3,096 bags, were manufactured in Thailand. They were supplied to eight public hospitals and 61 home patients of the public hospitals since June 2008.
Based on information available so far, the recall was made because of history of failure in initial sterility tests due to sample contamination. However, repeated sterility test before its release for sale was negative.
As a precautionary measure, the importer initiated a voluntary recall at patient level. The importer has so far contacted 20 patients and learnt that none of them had developed ill effects after using the product.
The DH will closely monitor the recall exercise.