Home / Recalls / Amgen, Inc. / D-0226-2017

D-0226-2017 Class II Terminated

Recalled by Amgen, Inc. — Thousand Oaks, CA

Recall Details

Product Type
Drugs
Report Date
December 28, 2016
Initiation Date
December 15, 2016
Termination Date
June 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,434 vials

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

Distribution Pattern

United States and Puerto Rico No foreign distribution.

Code Information

Lot #1071559, 1071629; Exp. 05/18

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  • D-1173-2017 Class II — Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL (September 13, 2017)
  • D-1086-2017 Class II — Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcuta (August 4, 2017)
  • D-66318-001 Class II — Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe p (September 17, 2013)