Drug 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.
D-0314-2021
Product summary
- Event
- Event 87489
- Status
- Terminated
- Classification
- Class III
- Quantity
- 48 boxes
- Official record key
drug-enforcement:D-0314-2021
Official wording
Reason: Temperature Abuse
Code information: KESOY.AI Exp. 04/2022
Distribution pattern: AL, LA, MS, TN
Derived failure modes
-
Unknown
Temperature Abuse