PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: April 7, 2021 Initiated: March 9, 2021 #D-0314-2021

Product Description

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

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
48 boxes
Distribution
AL, LA, MS, TN
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cardinal Health Inc.. Units affected: 48 boxes.
Why was this product recalled?
Temperature Abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on April 7, 2021. Severity: Low. Recall number: D-0314-2021.