Drug FDA Class II Ongoing cGMP deviation

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

McKesson Published Feb 5, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact McKesson or your place of purchase with questions, and see the source record below for full details.

Reason for recall

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Affected products (1)

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

INFLECTRA · 192 vials

NDC: 0069-0809, 0069-0809-01

Lot codes: 04647349

Code info: Lot# 04647349, Exp Date 5/31/2029

Affected areas

Nationwide

Timeline

Initiated

Jan 17, 2025
Published

Feb 5, 2025

Recall number: D-0213-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.