Fresenius Kabi recalls 0.45% Sodium Chloride Injection (250mL) with potential lack of sterility. This injectable solution is for prescription use only. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility
Fresenius Kabi is recalling a specific type of saline injection solution that may not be sterile. This could lead to infections if used improperly. The product is for prescription use only and was sold in 250mL bags.
The product lacks assurance of sterility, meaning it could contain harmful microorganisms. If injected, this might cause infections or other health issues. The risk is particularly concerning for medical procedures requiring sterile solutions.
Prescription patients using the recalled saline injection. Healthcare providers who administered this product may also be affected.
Check for the product name: 0.45% Sodium Chloride Injection, USP, 250 mL in a 250 mL freeflex bag. The NDC number 63323-626-03 (unit of use) or 63323-626-25 (30 bags per case) helps identify the recalled batch.
Reach out to Fresenius Kabi USA, LLC for specific instructions on handling the recalled product.
The recall states there is a lack of assurance of sterility, so it is not safe to use as it could cause infections.
Look for the NDC number 63323-626-03 (unit of use) or 63323-626-25 (30 bags per case) on the product label.
Contact Fresenius Kabi USA, LLC directly for specific instructions on disposal or return.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall D-0424-2026 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-0424-2026 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.
