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

Recall Number: D-1086-2017

Firm: Amgen, Inc.

Classification: Class II

Status: Terminated

Report Date: 20170823

Initiation Date: 20170804

Termination Date: 20180329

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

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