RecallDepth
Class II Terminated

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

Company
Amgen, Inc.
Recall Initiated
December 15, 2016
Posted
December 28, 2016
Recall Number
D-0226-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
11,434 vials
Firm Location
Thousand Oaks, CA, United States

Reason for Recall

Lack of Assurance of Sterility: Potential cracks in glass vials

Distribution

United States and Puerto Rico No foreign distribution.

Lot / Code Info

Lot #1071559, 1071629; Exp. 05/18

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