IGMPI India



Amgen recalls syringes of Aranesp due to presence of visible particulates

Amgen 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 presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life-threatening.

Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A were recalled as a precautionary measure. Till 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 is indicated for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis or in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. The impacted syringes were distributed in Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and UK.