Recall -- Firm Press Release
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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
Cuyler Mayer, 805-447-6332
Arvind Sood, 805-447-1060 (Investors)
FOR IMMEDIATE RELEASE - August 13, 2014 - 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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of August 13, 2014, and expressly disclaims any duty to update information contained in this news release.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.