Red Mountain Compounding Pharmacy recalls glutathione : FDA inspection found sterility assurance issues in all lots within expiry.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling glutathione 200mg/ml (Rx only) due to sterility concerns identified during FDA inspections. This could lead to infections if the product is not properly sterile.
FDA inspections found issues with the product's sterility assurance. This means the product might not be sterile, which could cause infections if used improperly.
Prescription patients who received this glutathione product from Red Mountain Compounding Pharmacy. Those with compromised immune systems may be at higher risk.
Check for the product name 'GLUTATHIONE 200MG/ML MDV' and the manufacturer 'Red Mountain Compounding Pharmacy'. All lots within the expiration date are affected.
Look for the product name 'GLUTATHIONE 200MG/ML MDV' and the manufacturer 'Red Mountain Compounding Pharmacy' on the label.
The FDA found sterility assurance concerns, so the product may not be sterile and could cause infections. Do not use until the recall is resolved.
The recall record does not specify a replacement or remedy.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Red Mountain Compounding Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0038-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0038-2022 from Red Mountain Compounding Pharmacy. 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.
