AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intraven...
FDA Recall #D-0226-2017 — Class II — December 15, 2016
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Potential cracks in glass vials
Recalling Firm
Amgen, Inc. — Thousand Oaks, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,434 vials
Distribution
United States and Puerto Rico No foreign distribution.
Code Information
Lot #1071559, 1071629; Exp. 05/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated