Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

USA-based Amgen (Nasdaq: AMGN) initiated a voluntary recall on June 26, 2014 for nine packaged lots of anemia drug Aranesp (darbepoetin alfa; 500mcg) prefilled syringes from non-US distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.

Lots are being recalled as a precautionary measure. To date, there have been no complaints or adverse events reported that can be attributed to the presence of these particles. Evaluations by Amgen found a very low potential to impact patients who may have received the affected product. Aranesp generated second-quarter sales of $517 million for Amgen, the world’s largest independent biotech company.

The US Food and Drug Administration has determined that health implications related to particles, depending on the route of administration, would vary depending on the amount of particulate matter injected into the patient, the size of the particles, the patient's underlying medical condition, and the presence of a right-to-left cardiac shunt. The presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life-threatening. This recall in non-U.S. jurisdictions is being conducted with the knowledge of the FDA.