Recalls / Class III
Class IIID-0314-2021
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.
- Brand name
- Tremfya
- Generic name
- Guselkumab
- Active ingredient
- Guselkumab
- Route
- Subcutaneous
- NDCs
- 57894-640, 57894-650, 57894-651
- FDA application
- BLA761061
- Affected lot / code info
- KESOY.AI Exp. 04/2022
Why it was recalled
Temperature Abuse
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Janssen Biotech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 48 boxes
- Distribution pattern
- AL, LA, MS, TN
Timeline
- Recall initiated
- 2021-03-09
- FDA classified
- 2021-03-29
- Posted by FDA
- 2021-04-07
- Terminated
- 2021-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0314-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.