FDA recall D-0213-2025

McKesson · Class II · drug

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

Status: Ongoing
Initiation date: 2025-01-17
Report date: 2025-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irving, TX, United States

Primary source

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