Red Mountain Compounding Pharmacy recalls all Dexpantenol 250mg/ml injections due to FDA sterility concerns from recent inspection. This medication is prescription-only.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling all Dexpantenol 250mg/ml injections because FDA inspections found sterility assurance issues. This could lead to infections if the medication is not properly sterile.
FDA inspections identified problems with ensuring the medication remains sterile. If the injection is not sterile, it could cause infections when administered into the body.
Prescription patients who have received this medication from Red Mountain Compounding Pharmacy. Those with medical conditions requiring this injection are at higher risk.
This product is a prescription-only injection labeled Dexpantenol 250mg/ml. It was sold by Red Mountain Compounding Pharmacy and includes all lots within the expiration date.
Look for the product name Dexpantenol 250mg/ml injection on your prescription label.
The FDA has raised sterility concerns, so the medication may not be safe for use. Consult your healthcare provider for advice.
The recall record does not specify a replacement process or remedy.
The product is available through Red Mountain Compounding Pharmacy but is now recalled.
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-0036-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0036-2022 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.
