Recalls / Class II
Class IID-0143-2026
Product
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0990-7730, 0990-7983, 0990-7984, 0990-7985
- FDA application
- NDA018090
- Affected lot / code info
- Lot # 1029921, Exp Date: 28 February 2027
Why it was recalled
Lack of Assurance of Sterility: Potential for flexible container leaks.
Recalling firm
- Firm
- Otsuka ICU Medical LLC
- Manufacturer
- ICU Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3900 Howard Ln, N/A, Austin, Texas 78728-6515
Distribution
- Quantity
- 509,360 100 mL bags
- Distribution pattern
- Distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2025-10-27
- FDA classified
- 2025-10-30
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0143-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.