FDAHealthOctober 27, 2025
Otsuka ICU Medical LLC — 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
⚠️ Lack of Assurance of Sterility: Potential for flexible container leaks.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 27, 2025
Distributed Nationwide in the USA.
What's affected?
- Product
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Brand
- SODIUM CHLORIDE
- Lot code
- 1029921
Additional details
Lot # 1029921, Exp Date: 28 February 2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 509,360 100 mL bags.
Get Health recall alerts
Delivered to your inbox. Free. No account required.