Nephron Sc recalls 5mL sterile water vials for drug dilution with potential trace product carryover. This affects specific lots and expiration dates. Consumers should check their vial details and contact the company for guidance.
CGMP Deviations: potential for trace amounts of product carryover.
Nephron Sc has recalled certain sterile water vials used for drug dilution due to potential trace amounts of product remaining in the vials. This could affect the safety of medications prepared using these vials.
The recall is due to potential trace amounts of product carryover in the vials. This could lead to unintended contamination when preparing medications, though the risk is considered low.
Healthcare professionals and pharmacies that use these vials for drug preparation. Those handling the recalled vials are most at risk.
Check for vials with lot numbers 124081, 124082 (expiring 04/2023) or 224031 (expiring 01/2024). The product is labeled as 'Sterile Water for Injection, USP, For Drug Diluent Use Only.'
Identify the lot number and expiration date on the vial to determine if it's part of the recall.
The recall is due to potential trace product carryover, which could affect medication preparation. The company recommends checking the specific lot numbers and expiration dates for affected vials.
The recall record does not specify a replacement process or remedy.
The recall record does not specify a remedy, so contact Nephron Sc directly for guidance.
We’ve drafted a message you can send Nephron Sc to request your refund or repair — edit it as you like.
Subject: Recall D-0178-2023 — Nephron Sc Nephron Sc Hello, I own a Nephron Sc that is covered by recall D-0178-2023 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.
