Certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. 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.
The affected product lot numbers and expiration dates are available at http://www.epogen.com and http://www.procrit.com.
Amgen has initiated recall letters which include instructions to return the referenced product to the returned goods service provider.
For more information on this recall,click here.