Red Mountain Compounding Pharmacy recalls benzalkonium chloride 0:013% solution (Rx only) due to FDA 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 benzalkonium chloride 0.013% solution (prescription-only) because an FDA inspection raised sterility concerns. This could lead to infections if the solution is not properly sterile.
The FDA inspection found concerns about the solution's sterility. If the solution is not sterile, it could cause infections when used for medical purposes. This is a serious issue for patients who require the solution for treatments.
Prescription patients who have been prescribed benzalkonium chloride 0.013% solution. Those most at risk are individuals with compromised immune systems or open wounds.
Check if you have benzalkonium chloride 0.013% solution (Rx only) from Red Mountain Compounding Pharmacy. All lots within the expiry date are included in this recall.
Look for the product name and lot number on the bottle to confirm if it's affected.
The FDA has raised sterility concerns, so the product may not be safe for medical use. Do not use it until the recall is resolved.
Check the product name and lot number on the bottle. All lots within the expiry date are affected.
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-0055-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0055-2022 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.
