Advanced Nutriceuticals recalls Pentosan Polysulfate vials due to potential lack of sterility in production. Affected lots may pose infection risks if used improperly.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Advanced Nutriceuticals is recalling Pentosan Polysulfate vials because production processes might not ensure sterility. Using these vials could lead to infections if they're not properly sterile.
The vials were produced without sufficient assurance of sterility. This means they might not be safe for medical use, potentially causing infections if used improperly.
People who purchased Pentosan Polysulfate vials from The Guyer Institute of Molecular Medicine in Indianapolis. Those using the product for medical purposes are most at risk.
Check for the lot number #1110202006 on the vial label. The vials were sold by The Guyer Institute of Molecular Medicine in Indianapolis, Indiana, with an expiration date of December 10, 2020.
Look for the lot number #1110202006 on the vial label to confirm if it's affected.
The recall states there's a lack of assurance of sterility, so it may not be safe for medical use. The product should not be used until the recall is resolved.
The recall record does not specify a remedy, so there's no action required beyond checking the lot number.
Check for the lot number #1110202006 on the vial label. The vials were sold by The Guyer Institute of Molecular Medicine in Indianapolis, Indiana, with an expiration date of December 10, 2020.
We’ve drafted a message you can send Advanced Nutriceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0144-2021 — Advanced Nutriceuticals Advanced Nutriceuticals Hello, I own a Advanced Nutriceuticals that is covered by recall D-0144-2021 from Advanced Nutriceuticals. 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.
