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.

FDA recall notice · announced April 7, 2021 · Cardinal Health

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: AL, LA, MS, TN
Lot/code information: KESOY.AI Exp. 04/2022
Quantity: 48 boxes
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.