FDAFDA · Food and drugs·Recall number D-0143-2026
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Published November 5, 2025 · Recall initiated: October 27, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Potential for flexible container leaks.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Otsuka ICU Medical LLC
- Distributor
- Distributed Nationwide in the USA.
- Lot
- Lot # 1029921, Exp Date: 28 February 2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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