Amgen, Inc. recalls 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…

Recall date

September 13, 2017

Source

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

Recall number

D-1173-2017

FDA classification

Class II

Brand / firm

Amgen, Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

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

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), 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