Natures Pharmacy recalls Tacrolimus 0.02% eye drops due to potential sterility issues from quality control failures observed during FDA inspection. All lots within expiry are affected.
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 is recalling all Tacrolimus 0.02% eye drops (H20-based) because their quality control procedures may have compromised sterility. This could lead to infections if the medication is used without proper sterility.
The pharmacy's quality control procedures during a recent FDA inspection showed potential risks to sterility assurance. This means the medication might not be sterile, increasing the chance of eye infections when used.
People who have received Tacrolimus 0.02% eye drops from Natures Pharmacy. Those with compromised immune systems or using the medication for chronic conditions are at higher risk of infection.
Check for the product name 'Tacrolimus 0.02% opth. (H20-based)' and all lot numbers within expiry dates. The recall covers all products compounded by Natures Pharmacy.
Look for the product name and lot number on the packaging to confirm if it's affected.
The recall indicates potential sterility issues, so it's not recommended to use the product without checking the recall status.
The official recall notice does not specify a replacement process.
The recall covers all lot numbers within expiry dates, but specific lot numbers are not listed.
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-1135-2014 — Natures Pharmacy & Compounding Center Natures Pharmacy & Compounding Center Hello, I own a Natures Pharmacy & Compounding Center that is covered by recall D-1135-2014 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.
