# FDA recall D-0213-2025

> **McKesson** · Class II · drug recall initiated 2025-01-17.

## Product

Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01

## Reason for recall

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0213-2025
- **Recalling firm:** McKesson
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-01-17
- **Report date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2025

## Citation

> AI Analytics. FDA recall D-0213-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0213-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*