Reported Feb 5, 2025 · Ongoing

Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by:…

McKesson

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: McKesson · 6555 State Highway 161 · Irving, TX · 75039-2402

Is this the product you have?

  • Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only
  • Mfd byCELLTRION, INC, Dist
  • byPfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
Lot codes and dates
    • Lot# 04647349
    • Exp Date 5/31/2029
Amount recalled
192 vials

Where it was sold

  • Nationwide

Why it was recalled

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:08 PM UTC

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