Class III
Terminated
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.
This recall has been terminated (originally issued April 7, 2021).
- Company
- Cardinal Health Inc.
- Recall Initiated
- March 9, 2021
- Posted
- April 7, 2021
- Recall Number
- D-0314-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 48 boxes
- Firm Location
- Dublin, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Temperature Abuse
Distribution
AL, LA, MS, TN
Lot / Code Info
KESOY.AI Exp. 04/2022
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