Red Mountain Compounding Pharmacy recalls estradiol valerate 5mg/ml injections (Rx only) due to FDA sterility assurance 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 estradiol valerate 5mg/ml injections (Rx only) because FDA inspections found sterility assurance issues. This could lead to infections if the product is used.
FDA inspections identified sterility assurance concerns with the injections. This means the product might not be sterile, potentially causing infections if used.
People with prescriptions for estradiol valerate 5mg/ml injections from Red Mountain Compounding Pharmacy. Those with the product are most at risk.
Check for the product name 'Estradiol Valerate 5mg/ml MDV INJ' with a prescription. All lots within expiry date are affected.
Look for the product name 'Estradiol Valerate : 5mg/ml MDV INJ' with a prescription.
FDA inspections raised sterility assurance concerns with the injections.
The recall notice does not specify a remedy.
Check the product details to see if it's affected; the recall covers all lots within expiry date.
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-0037-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0037-2022 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.
