Topic: Amgen Issues Voluntary Nationwide Recall of Certain Lots Procrit
If you are receiving Procrit please, discuss with your physician
The following is taken from the Amgen website
http://www.amgen.com/media/media_pr_det … ID=1474613
Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa)
THOUSAND OAKS, Calif., Sept 24, 2010 /PRNewswire via COMTEX/ --
Amgen (Nasdaq: AMGN) announced today that certain lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled 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. 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, L.P. 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.