Amgen Reports Recall Of Nine Packaged Lots Of Aranesp - Quick Facts

(RTTNews) - Amgen (AMGN) announced it has initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. 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.

The U.S. FDA 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.

The impacted syringes were distributed in Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and UK. The company said the Aranesp distributed in the U.S. is not impacted by the recall nor is product supply impacted.