Amgen Recalls Nine Packaged Lots of Aranesp Prefilled Syringes Due to Visible Particulates

Amgen reported in an August 13, 2014 press statement that it had 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 company is recalling Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A as a precautionary measure. To date, the company reports that 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.

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.

In the US, 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 potentially impacted product is Aranesp 500mcg prefilled syringes that were distributed outside of the United States. Aranesp distributed in the US is not impacted by the recall nor is product supply impacted

A single lot of Aranesp was packaged for different countries into nine packaged lots (lot numbers: 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A). The impacted syringes were distributed in Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and the UK. Amgen says it has completed notifications to the appropriate regulatory authorities.

Source: Amgen

Leave a Reply

Your email address will not be published. Required fields are marked *