Red Mountain Compounding Pharmacy recalls testosterone ultra 25:000mg/ml mdv in sesame oil (Rx only) after 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 is recalling testosterone ultra 250mg/ml mdv in sesame oil (prescription-only) due to sterility concerns identified by FDA. This could pose a risk of infection if the product is not properly sterile.
The FDA identified sterility assurance concerns during an inspection. This means the product might not be sterile, which could lead to infections if used improperly.
Prescription patients who have been prescribed testosterone ultra 250mg/ml mdv in sesame oil. Those with compromised immune systems may be at higher risk.
The product is testosterone ultra 250mg/ml mdv in sesame oil, prescription-only. All lots within the expiry date are affected.
Look for the product name and expiry date on the label to confirm if it's affected.
The FDA raised sterility concerns, so the product may not be sterile and could pose an infection risk.
Check the product label for testosterone ultra 250mg/ml mdv in sesame oil (prescription-only) and confirm it's within the expiry date.
The recall does not specify a remedy, so contact your healthcare provider for advice.
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-0050-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0050-2022 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.
