GenoGenix recalls all pH buffered reconstitution solutions for injection due to lack of assurance of sterility. This could lead to infections if used improperly.
Lack of Assurance of Sterility
GenoGenix is recalling all pH buffered reconstitution solutions for injection because they may not be sterile. Using these products could lead to infections, especially in medical settings.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or other contaminants. If used without proper sterilization, this could cause infections in patients.
Healthcare professionals and patients using this product for medical treatments are affected. Those with compromised immune systems may be at higher risk.
Check for the product labeled as pH Buffered Reconstitution Solution for Injection. All strengths and presentations are included in this recall. The product was manufactured for Medical Health Institute (MHI) and sold with a 10mL size.
Discard all pH buffered reconstitution solutions for injection immediately as they may not be sterile.
The recall states there is a lack of assurance of sterility, so it is not safe to use without discarding it.
Discard all pH buffered reconstitution solutions for injection immediately as they may not be sterile.
The recall includes all lots within expiry, so no specific lot numbers are needed.
We’ve drafted a message you can send GenoGenix to request your refund or repair — edit it as you like.
Subject: Recall D-0080-2026 — GenoGenix GenoGenix Hello, I own a GenoGenix that is covered by recall D-0080-2026 from GenoGenix. 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.
