Red Mountain Compounding Pharmacy recalls calcium gluconate 10% injectable (Rx only) 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 is recalling calcium gluconate 10% injectable (Rx only) because FDA inspections raised sterility concerns. This could lead to infections if the product is used.
The FDA found sterility assurance issues during inspections. If the product is not sterile, it could cause infections when injected into the body.
People who have been prescribed calcium gluconate 10% injectable (Rx only) from Red Mountain Compounding Pharmacy. Those with medical conditions requiring injections are at higher risk.
Check if you have calcium gluconate 10% injectable (Rx only) from Red Mountain Compounding Pharmacy. All lots within expiry date are affected.
Look for the product name and manufacturer on the label to confirm if it's affected.
The FDA raised sterility concerns, so the product may not be safe to use. Do not use until the recall is resolved.
The recall record does not specify a replacement process.
The recall record 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-0056-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0056-2022 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.
