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

FDA recall notice · announced February 5, 2025 · Mckesson

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Notes

Distribution: Nationwide USA
Lot/code information: Lot# 04647349, Exp Date 5/31/2029
Quantity: 192 vials
Status: Ongoing
Products in this recall event:
- 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 (D-0213-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.