Drug product
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
D-0428-2026
Product summary
- Event
- Event 98581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0428-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
Distribution pattern: US Nationwide , Alaska, and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility