# FDA recall D-0314-2021

> **Cardinal Health Inc.** · Class III · drug recall initiated 2021-03-09.

## 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

- **Recall number:** D-0314-2021
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0314-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0314-2021. Source: US FDA. Licensed CC0.

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