Otsuka ICU Medical product recalled over sterility concerns
- Recall date
- October 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Otsuka ICU Medical LLC recalls 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-79…
- Recall number
- D-0143-2026
- FDA classification
- Class II
- Brand / firm
- Otsuka ICU Medical LLC
- Sold / distributed
- Distributed Nationwide in the USA.
Why it was recalled
Lack of Assurance of Sterility: Potential for flexible container leaks.
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, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
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