Fresenius Kabi recalls a specific NORepinephrine injection product due to cGMP violations. This medication is for medical use only and should not be used without consulting a healthcare provider.
cGMP violations
Fresenius Kabi is recalling a specific NORepinephrine injection product because of manufacturing violations. This medication is for medical use only and should not be used without consulting a healthcare provider.
The product was manufactured in violation of current Good Manufacturing Practices (cGMP). This could lead to contamination or incorrect dosing, which may cause adverse effects if used improperly.
Healthcare providers and patients who have been prescribed this medication are affected. Those using the product without medical supervision are at risk.
The product is labeled as NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile. It has a specific NDC number (71506-025-58) and lot number (C274-000038582) with an expiration date of November 29, 2024.
Look for the NDC number 71506-025-58 and lot number C274-000038582 on the product label.
The product was recalled due to cGMP violations, so it is not safe for medical use without consulting a healthcare provider.
Contact your healthcare provider for guidance on whether to use the product or if it needs to be discarded.
The expiration date is November 29, 2024.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall D-0019-2025 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-0019-2025 from Fresenius Kabi. 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.
