Red Mountain Compounding Pharmacy recalls levocarnitine 100mg/ml solution for potential contamination risks. FDA inspection identified sterility assurance issues.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling levocarnitine 100mg/ml solution (Rx only) because FDA inspections found sterility concerns. This could lead to infections if the medication is not properly sterile.
The FDA inspection found that the sterility assurance for this medication was inadequate. This means the solution could be contaminated with bacteria, which might cause infections if used improperly.
People who have been prescribed levocarnitine 100mg/ml solution by a doctor. Those with compromised immune systems may be at higher risk.
Check if you have the levocarnitine 100mg/ml solution (Rx only) from Red Mountain Compounding Pharmacy. All lots within the expiration date are included in this recall.
Verify if your prescription contains the levocarnitine 100mg/ml solution from Red Mountain Compounding Pharmacy.
The FDA has identified sterility concerns, so it is not safe to use without recalling it. Consult your doctor for alternatives.
The recall does not specify a replacement process. Contact your doctor for alternative medications.
The recall is for sterility concerns, which could lead to infections but are not immediately life-threatening. Consult your doctor 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-0040-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0040-2022 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.
