FDAClass IIDecember 28, 2016

AMGEN Kyprolis recall: Sterility Concern

AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for…

Why was AMGEN Kyprolis recalled?

Lack of Assurance of Sterility: Potential cracks in glass vials

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #1071559, 1071629; Exp. 05/18

Product
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for…
Recalling firm
Amgen, Inc.
Quantity
11,434 vials
Distribution
United States and Puerto Rico No foreign distribution.
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls