FDAFDA · Food and drugs·Recall number D-0213-2025
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
Published February 5, 2025 · Recall initiated: January 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- INFLECTRA
- Manufacturer
- McKesson
- Distributor
- Nationwide USA
- UPC
- 0300690809014
- Lot
- Lot# 04647349, Exp Date 5/31/2029
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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