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Procrit, Epogen Recalled, Vials May Contain Glass Flakes

Sep 24, 2010 | Parker Waichman LLP

Some lots of Epogen and Procrit (Epoetin alfa) are being recalled today over concerns that some vials may be contaminated with extremely thin, barely visible gas flakes. A complete list of the affected lots is available here.

Procrit and Epogen are erythropoiesis-stimulating agents (ESAs). ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. They are used to treat anemia related to HIV therapy, chronic renal failure, and chemotherapy. The drugs are manufactured by Amgen Inc., but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement.

According to a statement from Amgen, the glass flakes resulted from the interaction of the drugs with their glass vials during the course of their shelf life. The affected lots of Procrit and Epogen are being recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution.

Use of the drugs could result in serious side effects, including, among other things, embolic, thrombotic and other vascular events (e.g., phlebitis). However, the Amgen statement maintains that there is a low potential to impact patients. According to the company’s statement, there have so far been no reports of adverse events that can be directly attributed to the presence of the glass flakes.

According to a report from The Wall Street Journal, Amgen is reducing the shelf life of Epogen to 12 months, from 36 months, for single-dose vials and 15 months for multiple-dose vials to prevent another occurrence. A spokesperson also told the Journal that the company will begin using glass vials from one of its manufacturers “that doesn’t exhibit the issue before the expiry date.” The company uses multiple suppliers, but wouldn’t comment on the source of the vials associated with this recall.

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