08/31/2026
Quality starts long before the finished product is tested.
On August 27, FDA issued an advisory after receiving reports of at least 30 patients who experienced adverse events following the administration of compounded IV glutathione. Reported events included fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms. Some patients required hospitalization.
The compounders involved had used glutathione labeled as dietary supplement grade. FDA states these ingredients are not appropriate for manufacturing injectable drugs because they may contain impurities or contaminants, including bacterial endotoxins.
At McGuff Outsourcing Solutions, we do not use dietary supplement-grade glutathione or raw material intended only for oral dietary supplement use to manufacture Glutathione Injection. Appropriate API sourcing, supplier qualification, incoming-material review, finished-batch testing and Quality Unit approval come before release. Each finished batch of MOS Glutathione Injection is tested for bacterial endotoxins and other applicable quality attributes.
That's why API quality isn't a checkbox for us — it's the foundation.
We will share a more detailed explanation of the FDA advisory soon: https://mcguff503b.com/fda-glutathione-injection-safety-quality
⚠️ DISCLAIMER: McGUFF PRODUCTS ARE FOR LICENSED HEALTHCARE PROFESSIONALS ONLY. They are not intended for direct consumer sale or use. Consult your trusted licensed healthcare professional for more information and guidance.
