Today, Amgen issued a voluntary recall of 201 lots of Epogen and 155 lots of Procrit (epoitin alfa) because of concern about very thin glass flakes in the vials. The flakes, or lamellae, result from the interaction of the formulation with the glass vials over the shelf life of the product.
The company has announced that according to evaluations conducted by Amgen and Centocor, the risk to patients who have received product included in the recall is low. To date, there have been no complaints or adverse events reported which can be directly attributed to the presence of glass lamellae.
Epogen and Procrit are both manufactured by Amgen. Epogen is sold by Amgen in the United States. Centocor Ortho Biotech Products is the authorized distributor of Procrit in the United States.
