March 2021 FDA Recall Tremfya by Cardinal Health Inc.
D-0314-2021 - Temperature Abuse
This Class III drug recall was voluntarily initiated by Cardinal Health Inc. on March 9, 2021 for the product Tremfya. The FDA reported the reason for recall as temperature abuse. The product was distributed in AL, LA, MS, TN and the recall is currently terminated.
Recall Number: D-0314-2021
Temperature Abuse
03-09-2021
04-07-2021
48 boxes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Cardinal Health 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.
AL, LA, MS, TN
11-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
