Recall of Erythropoiesis-Stimulating Agent Expanded
Janssen is expanding its voluntary recall of Procrit (epoetin alfa) 1mL single-dose, preservative-free solution to include two additional lots due to thin glass flakes (lamellae) observed during a routine inspection of the vials.
The latest recall applies to the following products:
- NDC# 59676-310-01; Lot#G290530A; Expiration date: 7/18
- NDC# 59676-310-02; Lot#G290531A; Expiration date: 7/18
Lot#G290530A consists of cartons containing 6 single-dose vials while Lot#G290531A consists of cartons containing 25 single-dose vials (both 10,000 units/mL).
Last month Janssen announced that it had initiated a recall of two separate Procrit lots (Lot#G290491A and Lot#G290491B). Administration of intravenous products that contain particulates could 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.
The recall is being conducted in coordination with the Food and Drug Administration and healthcare professionals are asked to examine their inventory for the referenced lots and to discontinue distribution if they are in possession of them.
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 1-800 JANSSEN or visit Procrit.com.