Amgen announced today that certain lots of
EPOGEN and PROCRIT (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.
