December 2016 FDA Recall Kyprolis by Amgen, Inc.
D-0226-2017 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Amgen, Inc. on December 15, 2016 for the product Kyprolis. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in United States and Puerto Rico No foreign distribution. and the recall is currently terminated.
Recall Number: D-0226-2017
Lack of Assurance of Sterility: Potential cracks in glass vials
12-15-2016
12-28-2016
11,434 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amgen, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States and Puerto Rico No foreign distribution.
06-02-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 1071559, 1071629; Exp. 05/18
