FDA recall D-0314-2021
Cardinal Health Inc. · Class III · 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.
Reason for recall
Temperature Abuse
Distribution
AL, LA, MS, TN
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-09
- Report date
- 2021-04-07
- Termination date
- 2021-11-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Dublin, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0314-2021