Safety Alerts & Recalls

What does this mean?

Evaluations by the manufacturers have found that patients who may have received the affected product are at a low risk for complications or side effects. The potential serious adverse events resulting from the use of a recalled product depend on the route of administration:

1) Given by the intravenous route, adverse events include formation of clots and other vascular events such as inflammation of the vein, and

2) Given by the subcutaneous route, adverse events include tissue encapsulation of the glass flake, local injection site reactions, and increased risk of an immune response such as a allergic reaction.

To date, there have been no complaints or adverse events reported which can be directly linked to the presence of glass flakes. You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this recalled Epogen or Procrit. Adverse events related to Epogen should be reported to 1-800-77-AMGEN. Adverse events related to Procrit should be reported to 1-800-547-6446. Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program by phone at 1-800-332-1088; by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch

Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week).

Amgen Issues Epogen/Procrit Voluntary Recall: Glass Flakes Found in VIals

Amgen announced today that certain lots of Epogen and Procrit (Epoetin alfa) vials are being voluntarily recalled from distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes that are barely visible in most cases. The glass flakes result from the interaction of the solution 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.

For more information and a complete list of recalled lot numbers, please visit: more information here

Source: Manufacturer
Publication Date: 2010-09-24
Last Updated: 2010-09-24

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