FDA Drug Class II — Moderate

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

Hazard

Lack of Assurance of Sterility: Potential cracks in glass vials

Products

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
Brand
Amgen, Inc.
UPC
Lot #1071559, 1071629; Exp. 05/18

Units Affected

11,434 vials