Kyprolis Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 76075-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Kyprolis (NDC 76075-101). A significant event, classified as Class II, was initiated on Dec 15, 2016 by Onyx Pharmaceuticals, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Potential cracks in glass vials"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Potential cracks in glass vials
Dec 15, 2016
Dec 28, 2016
11,434 vials
Recall Profile & Regulatory Data
Event ID
76012
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States and Puerto Rico No foreign distribution.
Termination Date
Jun 02, 2017
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
Batch or Lot Expiration Information
Lot# 1071559, 1071629; Exp. 05/18
Affected Packages Involved in this Recall
76075-101-01Product
76075-101-21Product
76075-102-01Product
76075-102-21Product
76075-103-01Product
76075-103-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
