Home / Recalls / Amgen, Inc. / D-1086-2017

D-1086-2017 Class II Terminated

Recalled by Amgen, Inc. — Thousand Oaks, CA

Recall Details

Product Type
Drugs
Report Date
August 23, 2017
Initiation Date
August 4, 2017
Termination Date
March 29, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
175,632 vials

Product Description

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

Reason for Recall

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

Distribution Pattern

United States including Puerto Rico

Code Information

Lot #: G290491A, G290491B, Exp. 06/18

Other recalls by Amgen, Inc.

  • D-0286-2025 Class II — Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL singl (February 27, 2025)
  • D-0285-2025 Class II — Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Onl (February 27, 2025)
  • D-0855-2022 Class II — MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 10 (May 2, 2022)
  • D-1173-2017 Class II — Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL (September 13, 2017)
  • D-0226-2017 Class II — AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused port (December 15, 2016)
  • D-66318-001 Class II — Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe p (September 17, 2013)