Drug product
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
D-0436-2026
Product summary
- Event
- Event 98581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0436-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.
Distribution pattern: US Nationwide , Alaska, and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility