California-based company recalls anemia drugs

LOS ANGELES, Sept. 24 (Xinhua) -- California-based biotechnology company Amgen announced on Friday that it is recalling certain lots of anemia drugs Epogen and Procrit because they may contain "extremely thin" glass flakes.
The glass flakes are "barely visible in most cases" and that there have been no complaints or serious events reported in relation to the glass flakes, Amgen said in a statement.
But there was "a low potential to impact patients who may have received the affected product," the statement said.
The "extremely" thin glass flakes have resulted from the interaction of the formulation with glass vials over the shelf life of the product, the statement said.
"Evaluations by Amgen and Centocor Ortho Biotech ... found a low potential to impact patients who may have received the affected product," the statement said.
The recall, being conducted in cooperation with the Food and Drug Administration, shouldn't disrupt the supply of the drug to patients, nor will it have a material financial impact on the company, said Amgen spokeswoman Emma Hurley.
Epogen and Procrit are manufactured in the United States by Amgen. Epogen is sold by Amgen in the United States, and Centocor Ortho Biotech is the authorized distributor of Procrit in the country.
"Amgen and Centocor Ortho Biotech Products and their affiliate companies have initiated recall letters and other communication to immediately inform relevant stakeholders, including healthcare professionals, distributors, wholesalers and pharmacies of the voluntary recall," the statement said.
Epogen is used to treat anemia in kidney failure patients who are on dialysis, and Procrit treats anemia in cancer patients receiving chemotherapy and in some patients with HIV.

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