FDARecalled Feb 5, 2025 · #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, ...
Hazard
Class II — temporary health risk
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cGMP Deviations: Product intended for quarantine was inadvertently distributed. Classification: Class II Distribution: Nationwide USA
Product details
- 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
- Type
- Drugs
- Manufacturer
- McKesson
- Model numbers
- 04647349
- UPCs
- —