FDARecalled Sep 17, 2025 · #D-0620-2025
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 ...
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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)
- Type
- Drugs
- Manufacturer
- Exela Pharma Sciences LLC
- Model numbers
- 10004077
- UPCs
- —