AMGEN Kyprolis for injection recalled over sterility concerns

Recall date

December 15, 2016

Source

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

Official notice title

Amgen, Inc. recalls AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only…

Recall number

D-0226-2017

FDA classification

Class II

Brand / firm

Amgen, Inc.

Sold / distributed

United States and Puerto Rico No foreign distribution.

Why it was recalled

Lack of Assurance of Sterility: Potential cracks in glass 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

AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01