It was announced by the pharmaceutical manufacture, Amgen, that they are recalling certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) The recall is prompted because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The products are used for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy, including prostate cancer chemotherapy.
Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product. However, 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 posted 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.
Additionally, adverse events should also be reported to 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
- Regular Mail: use postage-paid FDA form 3500 available at:
- Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
- Or by fax: 1-800-FDA-0178
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).
You should ask your physician or health care provider if they have experienced any problems that may be related to taking or using this drug product or if you are going to receive the drugs ask if your doctor has verified that their supply is not included in the recall.
Joel T Nowak, M.A., M.S.W.