0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reported: November 5, 2025 Initiated: October 27, 2025 #D-0143-2026
Product Description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason for Recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Details
- Recalling Firm
- Otsuka ICU Medical LLC
- Units Affected
- 509,360 100 mL bags
- Distribution
- Distributed Nationwide in the USA.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37. Recalled by Otsuka ICU Medical LLC. Units affected: 509,360 100 mL bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Potential for flexible container leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2025. Severity: Moderate. Recall number: D-0143-2026.
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