Edge Pharma recalls IV bags of ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) due to lack of sterility assurance. This may cause infections if used improperly.
Lack of Assurance of Sterility
Edge Pharma is recalling IV bags of ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) because they may not be sterile. Using these bags could lead to infections in patients receiving intravenous treatments.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or contaminants. If used in medical procedures, this could lead to infections in patients.
Patients receiving intravenous treatments with the recalled ALUM Concentrate IV bags. Healthcare providers using these bags for medical procedures are at risk.
The product is an IV bag labeled 'ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, Rx Only)' from Edge Pharma, LLC. It was sold between December 2021 and February 2022.
Look for the product name and manufacturer details on the IV bag.
The recall states there is a lack of assurance of sterility, so it is not safe to use without the remedy.
The recall record does not specify a remedy or replacement process.
The product was recalled starting in December 2021.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0394-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0394-2022 from Edge Pharma. 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.
