Jubilant Draximage recalls Draximage MAA kits due to endotoxin contamination. This kit is used for medical imaging and requires immediate attention if you have the specific lot number.
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Jubilant Draximage is recalling Draximage MAA kits because endotoxin testing showed out-of-specification results. This means the kits could be contaminated, which poses a risk to patients receiving medical imaging treatments.
Endotoxins are bacterial components that can cause severe infections or allergic reactions when introduced into the body. The out-of-specification endotoxin test results indicate the kits may contain harmful levels of these substances.
Healthcare professionals who use the Draximage MAA kits for medical imaging procedures are affected. Patients receiving these kits may be at risk if the contamination occurs.
Check for the product name 'Draximage MAA' with 2.5 mg per vial, 30 glass vials per carton. The lot number 1H005 and expiration date November 30, 2023 are specific to this recall.
Verify the product name, lot number, and expiration date to confirm if it matches the recalled items.
The recall indicates endotoxin testing was out of specification, so the product may be contaminated. Do not use until the manufacturer provides a remedy.
The recall record does not specify a remedy, so contact Jubilant Draximage directly for guidance.
Look for the product name 'Draximage MAA', 2.5 mg per vial, 30 glass vials per carton, lot number 1H005, and expiration date November 30, 2023.
We’ve drafted a message you can send Jubilant Draximage to request your refund or repair — edit it as you like.
Subject: Recall D-1189-2022 — Jubilant Draximage Jubilant Draximage Hello, I own a Jubilant Draximage that is covered by recall D-1189-2022 from Jubilant Draximage. 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.
