Amgen issues voluntary recall of Aranesp® (darbepoetin alfa) (500 mcg) prefilled syringes in several countries outside of the United States due to the presence of visible particulates

Amgen (NASDAQ:AMGN) 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. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A 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.

The U.S. Food and Drug Administration (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.

In the U.S., 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 which were distributed outside of the United States.

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). Aranesp distributed in the U.S. is not impacted by this recall nor is product supply impacted. The impacted syringes were distributed in Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and UK. Notifications to the appropriate regulatory authorities have been completed.

Consumers in the U.S. who have questions regarding this recall can contact Amgen at 1-800-77-AMGEN to arrange for the prompt return of the product (open 24 hours per day, 7 days per week).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall in non-U.S. jurisdictions is being conducted with the knowledge of the FDA.