Nephron recalls PF-Neostigmine Methylsulfate Injection vials due to potential cross-contamination during manufacturing. This medication is prescription-only and may be affected by lot NE1057A.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Nephron is recalling PF-Neostigmine Methylsulfate Injection vials because of a manufacturing issue that could cause cross-contamination. This affects prescription-only medication that may be used for nerve signal control in medical treatments.
The manufacturing process could lead to cross-contamination between vials, meaning one vial might contain medication from another product. This could cause unintended medication interactions or incorrect dosing in patients.
Prescription patients using this medication are affected. Healthcare providers who dispense the product may also be impacted.
Check for the Nephron brand, 3 mL vials labeled 'PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL', and the lot number NE1057A on the packaging.
Look for the lot number NE1057A on the vial packaging to confirm if it's affected.
The recall does not specify if the product is safe; it indicates a potential cross-contamination risk during manufacturing.
The recall record does not mention a remedy or replacement process.
The recall record does not specify actions for affected users beyond checking the lot number.
We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.
Subject: Recall D-1344-2022 — Nephron Nephron Hello, I own a Nephron that is covered by recall D-1344-2022 from Nephron. 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.
