Red Mountain Compounding Pharmacy recalls methylcobalamin 12.5mg/ml injection for potential sterility issues found during FDA 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 methylcobalamin 12.5mg/ml injection products because FDA inspections raised concerns about sterility. This could pose a risk of infection if the product is used.
FDA inspections found potential sterility issues with the product. This means the injection could be contaminated, leading to infection if used improperly.
People who have been prescribed methylcobalamin 12.5mg/ml injection by a doctor. Those using the product for medical treatment are most at risk.
Check for the product name 'Methylcobalamin 12.5mg/ml MDV INJ SOLN' on the label. All lots within the expiry date are included in this recall.
Look for the product name 'Methylcobalamin : 12.5mg/ml MDV INJ SOLN' on the label.
The FDA raised sterility concerns during inspection, so the product may not be safe. It is recommended to stop using and contact the manufacturer.
Check the product label for 'Methylcobalamin 12.5mg/ml MDV INJ SOLN' and ensure it is within the expiry date.
The recall does not specify a remedy, so contact the manufacturer directly 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-0060-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0060-2022 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.
