THOUSAND OAKS, Calif.—Amgen has issued a voluntary recall of certain lots of the anemia drugs Epogen and Procrit because they could contain thin glass flakes, according to a Sept. 24 news release.
Amgen said the lots being recalled might contain extremely thin glass flakes, called lamellae, that are “barely visible in most cases.” The lamellae result from the interaction of the formulation with glass vials over the shelf life of the products, according to Amgen.
The recall affects specialty distributors, wholesalers, pharmacies and healthcare providers.
Epogen is used to treat anemia in patients using dialysis. Procrit, which is distributed by Centocor Ortho Biotech, is used to treat anemia in cancer patients on chemotherapy and some HIV-infected patients.
Click HERE and scroll to the bottom of the page for a list of the affected lots.
After evaluating the anemia drugs, Amgen and Centocor Ortho Biotech said they “found a low potential to impact patients who may have received the affected product.”
There have been no complaints or adverse events reported which can be directly attributed to the presence of glass lamellae, according to Amgen.
However, the companies said the potential serious adverse events from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.
Amgen, which is working with the U.S. Food and Drug Administration on the recall, said any adverse events related to Epogen should be reported to (800) 77-AMGEN. Adverse events related to Procrit should be reported to (800) 547-6446.
Consumers with questions regarding this recall can contact Amgen at (800) 77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at (800) 547-6446 (open 24 hours per day, 7 days per week).
Adverse events can also be reported to the FDA at www.fda.gov/medwatch/report.htm.
