Natures Pharmacy recalls Lidocaine 4% Urethral Gel due to potential sterility issues from quality control failures observed during FDA inspection. Affected lots expire by specific dates.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Natures Pharmacy & Compounding Center is recalling Lidocaine 4% Urethral Gel because of concerns about sterility during compounding. This could pose a risk of infection if the product is used without proper sterility.
The product was compounded without proper sterility assurance due to quality control issues observed during an FDA inspection. This could lead to infections if the gel is used without being sterile.
People who purchased the recalled Lidocaine 4% Urethral Gel from Natures Pharmacy & Compounding Center. Those using the product for medical purposes are most at risk due to potential infection.
Check the lot numbers: 101213 (expires 04/14), 09202013 (expires 03/14), 08272013 (expires 02/14), or 08022013 (expires 01/14). The product expires by specific dates listed.
Look for the lot numbers listed: 101213, 09202013, 08272013, or 08022013.
The recall states there is a potential risk to sterility, so it is not safe to use without checking the lot number and following the recall instructions.
Check the lot number on the product. If it matches the recalled lots, stop using it and contact Natures Pharmacy & Compounding Center for further instructions.
The recall record does not mention a replacement option; the remedy is null.
We’ve drafted a message you can send Natures Pharmacy & Compounding Center to request your refund or repair — edit it as you like.
Subject: Recall D-1098-2014 — Natures Pharmacy & Compounding Center Natures Pharmacy & Compounding Center Hello, I own a Natures Pharmacy & Compounding Center that is covered by recall D-1098-2014 from Natures Pharmacy & Compounding Center. 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.
