McKesson recalls Inflectra (infliximab-dyyb) 100mg vials due to cGMP deviations where product intended for quarantine was distributed. This affects specific lots and requires immediate action.
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
McKesson is recalling Inflectra (infliximab-dyyb) 100mg per vial injections because some product meant for quarantine was accidentally distributed. This could pose a risk if the product is used without proper quality checks.
The product was intended for quarantine but was distributed due to a cGMP (current good manufacturing practice) deviation. This means the product may not meet quality standards and could be unsafe for use without proper testing.
Prescription drug users who have Inflectra (infliximab-dyyb) 100mg vials with lot number 04647349 are affected. Healthcare providers and patients using this specific product are most at risk.
Check for Inflectra (infliximab-dyyb) 100mg vials with lot number 04647349. The product was distributed by McKesson and manufactured by Celltrion, Inc.
Look for the lot number 04647349 on the Inflectra vial packaging.
The recall record states that product intended for quarantine was distributed, but it does not specify if the product is safe to use without further action.
The recall record does not provide a remedy, so the official notice does not specify what to do with the product.
Check the lot number on the Inflectra vial packaging; if it is 04647349, it is part of this recall.
We’ve drafted a message you can send McKesson to request your refund or repair — edit it as you like.
Subject: Recall D-0213-2025 — McKesson McKesson Hello, I own a McKesson that is covered by recall D-0213-2025 from McKesson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
