Red Mountain Compounding Pharmacy recalls sodium selinide injections (200mcg/ml) due to FDA sterility concerns from inspection. All lots within expiry date are affected.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling all sodium selinide injections (200mcg/ml) for injectable use because FDA inspections found sterility risks. This could lead to infections if the product is not sterile.
FDA inspections identified potential sterility issues with the product. This means the injections might not be sterile, which could cause infections if used improperly.
People who have received a prescription for sodium selinide injections from Red Mountain Compounding Pharmacy. Those with medical conditions requiring this medication are most at risk.
Check if you have sodium selinide injections (200mcg/ml) prescribed for injection. All lots within the expiry date are affected by this recall.
Look for the product name 'Sodium Selinide 200mcg/ml for injectable use' on your prescription label.
The FDA found sterility concerns, so the product may not be safe. Do not use until the recall is resolved.
All lots of sodium selinide injections (200mcg/ml) within the expiry date are affected by this recall.
Check the product details and contact the pharmacy for instructions on next steps.
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-0067-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0067-2022 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.
