RECALL - Epogen. Procrit. Glass Flakes.

[FDA Medwatch] Glass Flakes in Vials

(편집자 주 - 2010년 9월 25일 미국 FDA에서 보내온 에포젠 (Epogen) 과 프로크리트 (Procrit) 리콜 관련 내용입니다.)


Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials
AUDIENCE: Risk Manager, Oncology, Nephrology

ISSUE: Amgen and FDA notified healthcare professionals that certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible.

The potential serious adverse events resulting 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.

BACKGROUND: The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.

The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.

The affected product lot numbers and expiration dates are included in the table in the firm press release.

RECOMMENDATIONS: Amgen has initiated recall letters which include instructions to return the referenced product to the returned goods service provider.