Tremfya Injection
FDA Recall NDC 57894-640
Latest: Class III · Status: Terminated · Initiated Mar 09, 2021 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tremfya (NDC 57894-640). A significant event, classified as Class III, was initiated on Mar 09, 2021 by Janssen Biotech, Inc.. The reported reason for this action was: "Temperature Abuse"
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 III Terminated
Temperature Abuse
Mar 09, 2021
Apr 07, 2021
48 boxes
Recall Profile & Regulatory Data
Event ID
87489
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AL, LA, MS, TN
Termination Date
Nov 04, 2021
Product Description
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.
Batch or Lot Expiration Information
Lot# KESOY.AI Exp. 04/2022
Affected Packages Involved in this Recall
57894-650-01Tremfya
57894-650-02Tremfya
57894-640-01Tremfya
57894-640-04Tremfya
57894-640-11Tremfya
57894-640-99Tremfya
57894-640-03Tremfya
57894-640-06Tremfya
57894-651-01Tremfya
57894-651-02Tremfya
57894-651-04Tremfya
57894-651-11Tremfya
57894-651-22Tremfya
57894-651-99Tremfya
57894-651-92Tremfya
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.
