September 24, 2010
Amgen recalls certain lots of Epogen and ProcritAmgen and Centocor Ortho Biotech announced a voluntary nationwide recall of certain lots of Epogen (epoetin alfa) and Procrit (epoetin alfa) vials that may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The glass flakes resulted from the interaction of the formulation with glass vials over the shelf life of the product.
The affected lots of Epogen being recalled can be found at www.epogen.com/professional/pdf/epogen-consignee-notification-letter.pdf.
The affected lots of Procrit being recalled can be found at www.procrit.com/sites/default/files/pdf/Supplier_Procrit_Recall_Letter.pdf.
The manufacturers have found a low potential to impact patients who may have received the affected product. Potential serious adverse events by the intravenous route include embolic, thrombotic and other vascular events (eg, phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.
Epogen and Procrit are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.
For more information for Epogen call (800) 77-AMGEN or for Procrit call (800) 547-6446.