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.
Recall initiated: 20250117
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated