ESA Agent Recalled Due to Presence of Particulate in Vials
Janssen has initiated a recall for two lots of Procrit (epoetin alfa) 1mL single-dose preservative-free solution (cartons containing 4 single-dose vials; 40,000 Units/mL) due to the presence of thin glass flakes seen during the inspection of a very limited number of vials.
The recall applies to the following products:
- NDC# 59676-340-01; Lot#G290491A; Expiration date: 6/18
- NDC# 59676-340-01; Lot#G290491B; Expiration date: 6/18
Administration of intravenous products that contain particulates may potentially lead to embolic, thrombotic, or other vascular events (ie, phlebitis), while foreign body granuloma, local injection site reactions, and increased immunogenicity is possible with subcutaneous administration. Healthcare professionals are urged to following the package insert instructions regarding careful inspection of vials for particulate matter and discoloration before administration.
Procrit, an erythropoiesis-stimulating agent, is indicated for the treatment of anemia due to chronic renal failure, anemia related to zidovudine in HIV-infected patients, chemotherapy-induced anemia in patients with non-myeloid malignancies, and to reduce the need for allogeneic blood transfusions in anemic patients scheduled for elective, noncardiac, nonvasvular surgery.
For more information call (800) JANSSEN or visit www.Procrit.com.