Amgen, Inc. recalls Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured b…

Recall date

August 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1086-2017

FDA classification

Class II

Brand / firm

Amgen, Inc.

Sold / distributed

United States including Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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