Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Temperature Abuse
What was recalled
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.
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 57894-640-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0314-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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