Sept. 24, 2010 – Amgen announced today that certain lots of EPOGEN and PROCRIT vials are being voluntarily recalled as it may contain extremely thin glass flakes that are barely visible in most cases.
The lamellae (thin glass flakes) result from the interaction of the formulation with glass vials over the shelf life of the product. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.
Evaluations by Amgen and Centocor Ortho Biotech Products, LP found a low potential to impact patients who may have received the affected product. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. To date, there have been no complaints or adverse events reported which can be directly attributed to the presence of glass lamellae.
The affected product lot numbers and expiration dates are included in the table below and at www.epogen.com and www.procrit.com.
Adverse events related to EPOGEN should be reported to 1-800-77-AMGEN. Adverse events related to PROCRIT should be reported to 1-800-547-6446. Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week).
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
- Online: www.fda.gov/medwatch/report.htm
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Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. - Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178
Amgen and Centocor Ortho Biotech Products and their affiliate companies have initiated recall letters and other communication to immediately inform relevant stakeholders, including healthcare professionals, distributors, wholesalers and pharmacies of the voluntary recall. The letters include instructions to return the referenced product to the returned goods service provider.
The recall is being conducted in cooperation with the United States Food and Drug Administration.
EPOGEN and PROCRIT are manufactured in the United States by Amgen. EPOGEN is sold by Amgen in the United States. Centocor Ortho Biotech Products is the authorized distributor of PROCRIT in the United States.
About EPOGEN (Epoetin alfa)
EPOGEN is indicated for the treatment of anemia in patients with chronic renal failure on dialysis. EPOGEN is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
PROCRIT is licensed from Amgen and manufactured by Amgen in Puerto Rico.
CONTACT:
Amgen: Emma Hurley (media): 202-585-9647
Arvind Sood (investors): 805-447-1060
Centocor Ortho Biotech Products, L.P.:
Lisa Vaga (media): 908-218-7316 / 908-670-0363 (Cell)
