Red Mountain Compounding Pharmacy recalls calcium chloride injections (100 mg/mL MDV INJ, Rx only) after FDA inspection raised 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 has recalled calcium chloride injections (100 mg/mL MDV INJ, Rx only) due to sterility concerns identified during an FDA inspection. This recall affects all lots within the expiry date, and users should contact the pharmacy for guidance.
FDA inspections found insufficient sterility assurance in the calcium chloride injections. This could lead to infections if the medication is not properly sterile, especially for patients receiving injections.
People who have been prescribed calcium chloride injections by a healthcare provider. Those with medical conditions requiring this medication are most at risk.
Check for the product name 'Calcium Chloride, 100 mg/mL MDV INJ, Rx only' from Red Mountain Compounding Pharmacy. All lots within the expiry date are affected.
Reach out to Red Mountain Compounding Pharmacy directly for specific instructions on handling the recalled product.
The FDA identified sterility concerns, so the product is not safe for use. Contact the pharmacy for guidance.
Check for the product name 'Calcium Chloride, 100 mg/mL MDV INJ, Rx only' from Red Mountain Compounding Pharmacy. All lots within the expiry date are affected.
Contact Red Mountain Compounding Pharmacy directly for specific instructions on handling the recalled product.
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-0028-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0028-2022 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.