FDA Drug recall D-0314-2021
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., H…
- FDA Drug
- Class III
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class III recall of Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., H… by Cardinal Health, citing temperature Abuse.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0314-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-03-09 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | AL, LA, MS, TN |
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
Temperature Abuse
Identifiers
| ndc | 57894-650-01 |
|---|---|
| ndc | 57894-650-02 |
| ndc | 57894-640-01 |
| ndc | 57894-640-04 |
| ndc | 57894-640-11 |
| ndc | 57894-640-99 |
| ndc | 57894-640-03 |
| ndc | 57894-640-06 |
| ndc | 57894-651-01 |
| ndc | 57894-651-02 |
| ndc | 57894-651-04 |
| ndc | 57894-651-11 |
| ndc | 57894-651-22 |
| ndc | 57894-651-99 |
| ndc | 57894-651-92 |
| code_info | KESOY.AI Exp. 04/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0314-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.