Natures Pharmacy recalls sterile Sodium Bicarbonate 8.4% injections due to potential sterility issues from quality control concerns observed during FDA inspection.
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 all sterile Sodium Bicarbonate 8.4% injections because quality control issues during an FDA inspection raised concerns about sterility. This could lead to infections if the product is used without proper sterility.
The product was compounded by the pharmacy without proper sterility assurance due to quality control issues observed during an FDA inspection. This could lead to infections if the product is used without proper sterility.
Patients using sterile Sodium Bicarbonate 8.4% injections for medical purposes. Those who have recently received this product from Natures Pharmacy are most at risk.
Check the product label for 'Sodium Bicarbonate 8.4% inj.' and the lot number. This product was sold by Natures Pharmacy & Compounding Center.
Look for the product name 'Sodium Bicarbonate 8.4% inj.' and the lot number on the label.
The FDA observed quality control issues during an inspection that raised concerns about sterility assurance for this product.
The recall notice does not specify a remedy.
Check the product label for 'Sodium Bicarbonate 8.4% inj.' and the lot number.
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-1131-2014 — Natures Pharmacy & Compounding Center Natures Pharmacy & Compounding Center Hello, I own a Natures Pharmacy & Compounding Center that is covered by recall D-1131-2014 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.
