Amgen initiated a voluntary recall on June 26th for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality check. The lots are being recalled as a precautionary measure, and to date, there have been no adverse events reported attributed to the presence of these particles.
The FDA has determined that health implications related to the particles would vary, depending on route of administration, amount of particulate matter injected, size of the particles, and the patient's underlying medical condition, which may elicit inflammatory and allergic responses, and may be life-threatening.
In the U.S., Aranesp is indicated for the treatment of anemia associated with chronic renal failure, or in patients with non-myeloid malignancies with chemotherapy induced anemia. Aranesp distributed in the U.S. is not impacted by this recall.