Breaking News

Amgen Recalls Lots of Aranesp

August 14, 2014

Prefilled syringes outside U.S. have potential presence of visible particulates

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.
blog comments powered by Disqus
  • Quality Risk Management

    Quality Risk Management

    Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016
    Embracing the process as a means to a strong quality culture

  • Staying Ahead in the Small Molecule Space

    Staying Ahead in the Small Molecule Space

    Dr. Matthew Moorcroft, VP Global Marketing, Cambrex||September 8, 2016
    Understand what is happening in the market and react accordingly

  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments