Nephron recalls PF-Neostigmine Methylsulfate Injection vials due to potential cross contamination from product carry over. Affected lots expire by December 2022. Contact for remedy.
CGMP Deviations: Potential for cross contamination due to product carry over.
Nephron is recalling PF-Neostigmine Methylsulfate Injection vials that may have cross contamination due to product carry over. This is a medication recall for healthcare professionals using these vials for prescription treatments.
The recall is for potential cross contamination from product carry over during manufacturing. This could lead to unintended medication mix-ups in sterile compounding processes.
Healthcare professionals who use this medication for prescription treatments. Patients receiving this medication from a provider using recalled vials are at risk.
Check for vials labeled PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL), Rx Only, Nephron 503B Outsourcing Facility 4500. Look for specific lot numbers: NE1062A/B, NE1065A/B, or NE2011A/B with expiration dates by December 2022.
Identify the lot number and expiration date on the vial to determine if it is affected.
The recall is due to potential cross contamination from product carry over during manufacturing, which could lead to unintended medication mix-ups.
Check the lot number and expiration date on the vial. If it matches the affected lots listed, contact Nephron for further instructions.
The recall record does not specify a remedy.
We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.
Subject: Recall D-0065-2023 — Nephron Nephron Hello, I own a Nephron that is covered by recall D-0065-2023 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.
