After observing cellulose and/or polyester particles in a small number of pre-filled syringes of Aranesp (darbepoetin alfa) during a routine quality check, Amgen (AMGN) initiates a voluntary recall of nine lots of the product.
Evaluations by the company found a very low potential to impact patients who may have received an affected product. However, the FDA determined that the health implications depend on a number of variables. Patients injected with a solution containing particulate foreign matter could experience chronic and acute inflammatory and/or allergic responses that could be life-threatening.
None of the recalled lots were distributed in the U.S. The lots were shipped to various countries in Europe and the Middle East.