Inflectra recalled over manufacturing violations

Recall date

January 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

McKesson recalls Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTR…

Recall number

D-0213-2025

FDA classification

Class II

Brand / firm

McKesson

Sold / distributed

Nationwide USA

Why it was recalled

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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