Red Mountain Compounding Pharmacy recalls all PYRIDOXINE HCL (B6) : FDA inspection raised sterility assurance concerns. No remedy specified in recall notice.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling all PYRIDOXINE HCL (B6) 100MG/ML MDV products due to sterility concerns identified during FDA inspection. This could pose a risk of infection if the medication is not properly sterile.
The FDA inspection found issues with the sterility assurance process for this medication. If the product is not sterile, it could cause infections when injected or taken orally.
People who have received this medication from Red Mountain Compounding Pharmacy are affected. Those with medical conditions requiring vitamin B6 supplements may be at higher risk.
Check for the product name 'PYRIDOXINE HCL (B6) 100MG/ML MDV' from Red Mountain Compounding Pharmacy. All lots within the expiration date are included in this recall.
Look for the product name 'PYRIDOXINE HCL (B6) 100MG/ML MDV' from Red Mountain Compounding Pharmacy.
The recall notice does not specify any remedy.
FDA inspection raised sterility assurance concerns, which could lead to infections if the product is not properly sterile.
People with medical conditions requiring vitamin B6 supplements may be at higher risk due to potential infection from non-sterile medication.
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-0041-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0041-2022 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.
