Nephron Sc recalls 100mL 0.9% Sodium Chloride Injection due to potential trace product carryover from manufacturing. This is a drug product for medical use only.
CGMP Deviations: potential for trace amounts of product carryover.
Neph: Nephron Sc has recalled 100mL 0.9% Sodium Chloride Injection (medical saline) because of potential trace amounts of product carryover during manufacturing. This could affect safety if used improperly.
During manufacturing, trace amounts of the product may remain on equipment, potentially leading to contamination. This could cause minor safety issues if the saline is used incorrectly.
Healthcare professionals who use this saline for medical procedures. Patients receiving this injection are not directly affected as it's a prescription-only product.
Check for the NDC code 0487-4301-10 on the container. The product was sold with lot number 271043 and expires March 2023.
Verify the NDC code 0487-4301-10 and lot number 271043 on the container.
The recall is due to potential trace product carryover during manufacturing, but the product is still considered safe for medical use under normal conditions.
Look for the NDC code 0487-4301-10 and lot number 271043 on the container.
The recall does not require immediate action; check the product details and contact Nephron Sc if you have concerns.
We’ve drafted a message you can send Nephron Sc to request your refund or repair — edit it as you like.
Subject: Recall D-0177-2023 — Nephron Sc Nephron Sc Hello, I own a Nephron Sc that is covered by recall D-0177-2023 from Nephron Sc. 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.