Drug product
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).
D-0424-2026
Product summary
- Event
- Event 98581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0424-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch # 6402413, Exp Date: 02/29/2028
Distribution pattern: US Nationwide , Alaska, and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility