Red Mountain Compounding Pharmacy recalls methylcobalamin injections (1000mcg/ml) after FDA inspection raised 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 methylcobalamin injections (1000mcg/ml) because an FDA inspection found sterility assurance concerns. This could lead to infections if the product is used.
The FDA inspection identified issues with sterility assurance, meaning the product might not be sterile. If the injection is not sterile, it could cause infections when used in the body.
Prescription patients who received methylcobalamin injections from Red Mountain Compounding Pharmacy. Those with compromised immune systems are at higher risk.
Check for methylcobalamin injections labeled 1000mcg/ml, prescription-only, from Red Mountain Compounding Pharmacy. All lots within expiry date are affected.
Look for the product name 'METHYLCOBALAMIN 1000MCG/ML MDV INJ' and prescription label.
The FDA inspection raised sterility concerns, so the product may not be safe. Do not use until the recall is resolved.
Check for methylcobalamin injections labeled 1000mcg/ml, prescription-only, from Red Mountain Compounding Pharmacy.
The recall does not specify a remedy, so contact the manufacturer 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-0059-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0059-2022 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.
