Drug product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
D-0369-2022
Product summary
- Event
- Event 89402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,960 vials
- Official record key
drug-enforcement:D-0369-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: C0001088/P0001317, Exp. Date 08/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility