Recalling firm
McKesson
Product type
Drug
Status
Ongoing
Report date
2025-02-05
Distribution
Nationwide USA
Firm state
TX
Product quantity
192 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Product description
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
Code / lot info
Lot# 04647349, Exp Date 5/31/2029
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.