Red Mountain Compounding Pharmacy recalls methylcobalamin injections (10,000mcg/ml) after FDA inspection raised sterility assurance concerns. No remedy specified in recall notice.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling methylcobalamin injections (10,0:000mcg/ml) because an FDA inspection found sterility assurance issues. This could lead to infections if the product is used.
The FDA inspection identified concerns about the product's sterility assurance. If the injections are not sterile, they could cause infections when injected into the body.
People who have received a prescription for methylcobalamin injections from Red Mountain Compounding Pharmacy. Those with compromised immune systems are at higher risk.
Check for the product name 'Methylcobalamin 10,000mcg/ml MDV INJ' on the label. The recall includes all lots within the expiration date.
Look for the product name 'Methylcobalamin 10,000mcg/ml MDV INJ' on the label.
The recall notice does not specify any remedy.
An FDA inspection raised sterility assurance concerns.
People with compromised immune systems are at higher risk.
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-0058-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0058-2022 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.
