Red Mountain Compounding Pharmacy recalls cyclosporine 2% MCT oil suspension (Rx only) due to FDA sterility concerns. All lots within expiry date are affected.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy has recalled all cyclosp: 2% MCT oil suspension products (prescription-only) because FDA inspections found sterility risks. This could lead to infections if the medication isn't properly sterile.
FDA inspections identified potential sterility issues with the medication. If the product isn't sterile, it could cause infections in patients who use it.
Prescription patients using cyclosporine 2% MCT oil suspension from Red Mountain Compounding Pharmacy. Those with compromised immune systems are at higher risk.
Check for the product name 'Cyclosporine 2% MCT Oil Suspension' on prescription labels. All lots within the expiry date are affected.
Look for the product name 'Cyclosporine 2% MCT Oil Suspension' on prescription labels.
The FDA raised sterility concerns, so the product is not safe for use without a recall remedy. However, the remedy is not specified in the recall notice.
Check for the product name 'Cyclosporine 2% MCT Oil Suspension' on prescription labels. All lots within the expiry date are affected.
The recall notice 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-0035-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0035-2022 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.
