Drug product
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
D-0620-2025
Product summary
- Event
- Event 97348
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0620-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Code information: Lot # 10004077, Exp. 02/28/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification