Nephron recalls Trisodium Citrate 0.5% Solution (0.5%/4L) due to potential cross-contamination during manufacturing. This product is prescription-only and may be found in specific lots.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Nephron is recalling Trisodium Citrate 0.5% Solution (0.5%/4L) because manufacturing errors could cause cross-contamination. This poses a risk to patients using the product for medical purposes.
The product was manufactured at a facility where cross-contamination could occur during production. This means other medications might mix with the solution, potentially causing adverse reactions in patients.
Patients prescribed this solution for medical use. Healthcare providers handling the product are most at risk due to the prescription-only nature.
Check for the NDC code 69374-910-04 on the packaging. Look for lots TC2007D (expires 8/26/2022) or TC2010A (expires 9/25/2022). The product is prescription-only and sold in 4L IV bags.
Verify the NDC code 69374-910-04 and lot numbers TC2007D or TC2010A on the packaging.
The recall is due to potential cross-contamination during manufacturing, but the product is prescription-only and may still be safe if used correctly. Consult your healthcare provider.
Check for the NDC code 69374-910-04 and lot numbers TC2007D (expires 8/26/2022) or TC2010A (expires 9/25/2022) on the packaging.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to continue using the product.
We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.
Subject: Recall D-1345-2022 — Nephron Nephron Hello, I own a Nephron that is covered by recall D-1345-2022 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.
