FDAHealthJanuary 17, 2025
McKesson — 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
⚠️ cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 17, 2025
Nationwide USA
What's affected?
- 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
- Brand
- INFLECTRA
- UPC
- 0300690809014
- Lot code
- 04647349
Additional details
Lot# 04647349, Exp Date 5/31/2029
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 192 vials.
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