Class II
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
Lack of Assurance of Sterility
- Recall number
- D-0424-2026
- Report date
- April 15, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Fresenius Kabi USA, LLC
- Generic names
- SODIUM CHLORIDE
- Brand names
- SODIUM CHLORIDE
- Product NDCs
- 63323-626
Code and lot information
Batch # 6402413, Exp Date: 02/29/2028
Distribution
US Nationwide , Alaska, and Puerto Rico.
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.