Class II
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.
- Recall number
- D-0143-2026
- Report date
- November 5, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Otsuka ICU Medical LLC
- Generic names
- SODIUM CHLORIDE
- Brand names
- SODIUM CHLORIDE
- Product NDCs
- 0990-7730, 0990-7983, 0990-7984, 0990-7985
Code and lot information
Lot # 1029921, Exp Date: 28 February 2027
Distribution
Distributed Nationwide in the USA.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.