Drug product
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
D-0425-2026
Product summary
- Event
- Event 98581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0425-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.
Distribution pattern: US Nationwide , Alaska, and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility