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Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, R...

FDA Recall #D-0213-2025 — Class II — January 17, 2025

Recall #D-0213-2025 Date: January 17, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

McKesson — Irving, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

192 vials

Distribution

Nationwide USA

Code Information

Lot# 04647349, Exp Date 5/31/2029

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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