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

Recall Number: D-0213-2025

Firm: McKesson

Classification: Class II

Status: Ongoing

Report Date: 20250205

Initiation Date: 20250117

Termination Date:

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

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