FDAFDA · Food and drugs·Recall number D-0314-2021
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.
Published April 7, 2021 · Recall initiated: March 9, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Temperature Abuse
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TREMFYA
- Manufacturer
- Cardinal Health Inc.
- Distributor
- AL, LA, MS, TN
- Lot
- KESOY.AI Exp. 04/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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