Fresenius Medical Care Holdings product recalled over sterility concerns
- Recall date
- May 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,…
- Recall number
- D-0490-2025
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Holdings, Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
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