Lots of Epogen and Procrit Recalled Due to Glass Flakes in Vials

Emma Hitt, PhD

Disclosures

September 27, 2010

September 27, 2010 — Certain lots of epoetin alfa (Epogen and Procrit; Amgen) vials are being recalled because they may contain lamellae (extremely thin, barely visible glass flakes), the US Food and Drug Administration (FDA) announced September 24.

According to an alert from MedWatch, the FDA's safety information and adverse event reporting program, the manufacturer and the FDA notified are recalling the lots because of the potential for serious adverse events, such as embolic, thrombotic, and other vascular events that may occur if particulate matter is introduced into the bloodstream.

According to the manufacturer, the lamellae result from the interaction of the formulation with glass vials during the shelf life of the product. However, the company states that it has found that the lamellae have a low potential to affect patients who may have received the recalled product. "To date, there have been no complaints or adverse events reported which can be directly attributed to the presence of glass lamellae," the company notes.

Amgen has sent out recall letters that include instructions on how to return the product. The affected product lot numbers and expiration dates are included in the company's press release.

More information on Friday's recall is available on the FDA's Web site.

Epoetin alfa is indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.

Healthcare professionals and patients are encouraged to report adverse events related to the use of epoetin alfa to the manufacturer at 1-800-77-AMGEN. In addition, adverse events related to these products can be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....