FDA-Drug2021-04-07Class III

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.

Hazard

Temperature Abuse

Sold states
AL, LA, MS, TN
Affected count
48 boxes
Manufactured in
7000 Cardinal Pl, Dublin, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0314-2021

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