Here is an alert for anyone being treated with the products EPOGEN® and PROCRIT®:
Certain lots of EPOGEN and PROCRIT vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers because they may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.
These products are prescribed for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.
A letter is available on www.procrit.com prefaced “Urgent Drug Product Recall” that lists all of the lot numbers of PROCRIT® that were recalled on September 22, 2010. A list of recalled lot numbers of EPOGEN® has been supplied by the FDA.
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.
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:
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
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.
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.
List of EPOGEN lot numbers: http://www.fda.gov/Safety/Recalls/ucm227202.htm
List of PROCRIT lot numbers: