FDA recall D-0226-2017

Product

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

United States and Puerto Rico No foreign distribution.

Key facts

Status

Terminated

Initiation date

2016-12-15

Report date

2016-12-28

Termination date

2017-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2017