Amgen said that the lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.
Epogen and Procrit are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.
Amgen and Centocor Ortho Biotech Products evaluated the recalled products and found a low potential to impact patients who may have received the affected product.
Amgen cautioned that 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 and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.
Reportedly, Amgen informed that no complaints or adverse events have been reported till date, which can be directly attributed to the presence of glass lamellae.
Epogen is sold by Amgen in the US, while Centocor Ortho Biotech Products is the authorised distributor of PROCRIT in the US.