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Biotechnology firm Amgen has recalled hundreds of thousands of two anaemia treatment drugs, which could be contaminated with thin glass flakes, as a precautionary measure.
Erythropoietin-based products Epogen and Procrit lift red cell counts in anaemia caused by chronic renal failure, cancer chemotherapy and HIV treatment.
Johnson & Johnson’s Centocor Ortho Biotech subsidiary, which sells Procrit on licence, says about 324,000 vials of its product have been recalled, although Amgen did not specify how many individual products have been affected overall. The lots included in the recall have expiry dates ranging from September 2010 to June 2013.
An Amgen statement said there was “low potential” for side effects among people taking the drugs. Side effects could include embolic, thrombotic and other vascular reactions, if the product is given intravenously, and foreign body granuloma, local injection site reactions and increased immunogenicity, if given by the subcutaneous route.
The flakes – known as lamellae – are said to result from the reaction of the Epogen and Procrit formulations with the glass vials over the shelf life of the product.
Copyright Press Association 2010