US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 13, 2017 (9 years ago)

Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

What was recalled

Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044

Recalling firm
Amgen, Inc.
NDC code
59676-310-01
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1173-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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