FDAFDA · Food and drugs·Recall number D-0226-2017
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
Published December 28, 2016 · Recall initiated: December 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Potential cracks in glass vials
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KYPROLIS
- Manufacturer
- Amgen, Inc.
- Distributor
- United States and Puerto Rico No foreign distribution.
- Lot
- Lot #1071559, 1071629; Exp. 05/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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