Drug product
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
D-0303-2025
Product summary
- Event
- Event 96481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 103,950 vials
- Official record key
drug-enforcement:D-0303-2025
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 10006417 and 10006418, Exp. 11/30/2026
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility