Red Mountain Compounding Pharmacy recalls methylcobalamin injections (5000mcg/ml) 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 methylcobalamin injections (5000mcg/ml) because FDA inspections found sterility assurance issues. This could lead to infections if the product is used.
FDA inspections identified sterility assurance concerns, meaning the injections might not be sterile. Using non-sterile injections can cause infections, especially in vulnerable individuals.
Prescription patients who received methylcobalamin injections from Red Mountain Compounding Pharmacy. Those with compromised immune systems are at higher risk.
Check for the product name 'Methylcobalamin 5000mcg/ml MDV INJ' on the label. All lots within the expiry date are affected.
Look for the product name 'Methylcobalamin 5000mcg/ml MDV INJ' on the label.
The FDA raised sterility concerns, so the product may not be sterile and could cause infections. Do not use.
Check the label for 'Methylcobalamin 5000mcg/ml MDV INJ' and ensure it was purchased 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-0061-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0061-2022 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.
