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
Reported: February 5, 2025 Initiated: January 17, 2025 #D-0213-2025
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
Reason for Recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Details
- Recalling Firm
- McKesson
- Units Affected
- 192 vials
- Distribution
- Nationwide USA
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by McKesson. Units affected: 192 vials.
Why was this product recalled? ▼
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2025. Severity: Moderate. Recall number: D-0213-2025.
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