Red Mountain Compounding Pharmacy recalls specific sterile medication products due to FDA sterility assurance concerns. All lots within expiry date are affected. Consumers should contact the pharmacy for details.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling certain sterile medication products because an FDA inspection raised concerns about sterility assurance. This means the medication may not be safe for use, and affected consumers should stop using it and contact the pharmacy.
The FDA inspection found that the sterility assurance for these medications was inadequate. This means the medication could be contaminated with harmful bacteria, which could cause serious infections if used improperly.
People who have received the recalled medication products from Red Mountain Compounding Pharmacy. Those with prescription medication for medical conditions are at the highest risk.
The recalled products are labeled as MIC 25/50/5:50MG/ML MDV, Rx only, and Red Mountain Compounding Rx. All lots within the expiry date are affected.
Immediately stop using the recalled medication products as they may be contaminated with harmful bacteria.
The FDA inspection raised concerns about sterility assurance for these medication products, meaning they may not be safe for use.
Stop using the medication immediately and contact Red Mountain Compounding Pharmacy for further instructions.
All lots within the expiry date are affected, but specific lot numbers are not mentioned in the recall notice.
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-0062-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0062-2022 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.