FDA-Drug2025-09-17Class II
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)
Exela Pharma Sciences LLC
Hazard
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Sold states
Nationwide in the USA
Affected count
N/A
Manufactured in
1245 Blowing Rock Blvd, N/A, Lenoir, NC, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0620-2025Don't want to check this manually?
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