FDA-Drug2025-02-05Class II
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
McKesson
Hazard
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Sold states
Nationwide USA
Affected count
192 vials
Manufactured in
6555 State Highway 161, Irving, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2025Don't want to check this manually?
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