FDA Drug Class II — Moderate

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01

Hazard

Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

Products

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products,
Brand
Amgen, Inc.
UPC
Lot #: G290491A, G290491B, Exp. 06/18

Units Affected

175,632 vials