Reported Aug 23, 2017 · Terminated

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

Amgen, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amgen, Inc. · 1 Amgen Center Dr · Thousand Oaks, CA · 91320-1730

Is this the product you have?

  • Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only
  • Manufactured byAmgen Inc., Thousand Oaks, CA 91320-1799
  • Manufactured forJanssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Lot codes and dates
    • Lot #: G290491A
    • G290491B
    • Exp. 06/18
Amount recalled
175,632 vials

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 29, 2018 · Data as of Sep 19, 5:52 PM UTC

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