Red Mountain Compounding Pharmacy recalls levocarnitine 100mg/ml solution for prescription use due to FDA sterility concerns. All lots within expiry date are affected.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy has recalled all lots of levocarnitine 100mg/ml solution for prescription use because FDA inspections found sterility assurance issues. This could lead to infections if the medication is not properly sterile.
FDA inspections identified sterility assurance concerns with the medication. This means the solution might not be sterile, which could cause infections if used improperly.
Prescription patients using levocarnitine 100mg/ml solution from Red Mountain Compounding Pharmacy. Those with medical conditions requiring this medication are most at risk.
Check for the product name 'LEVOCARNITINE 100MG/ML MDV SOLN' on prescription labels. All lots within the expiry date are affected by this recall.
Look for the product name 'LEVOCARNITINE 100MG/ML MDV SOLN' on prescription labels.
The FDA has raised sterility concerns, so the product is not considered safe for use without the recall remedy.
Check for the product name 'LEVOCARNITINE 100MG/ML MDV SOLN' on prescription labels. All lots within the expiry date are affected.
The recall remedy is not specified in the official notice, so contact the manufacturer directly 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-0030-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0030-2022 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.
