Brand
Exela Pharma Sciences LLC
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Exela Pharma Sciences LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-17FDA-DrugClass II4.2% 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)
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
- 2025-04-02FDA-DrugClass II8.4% 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
Lack of Assurance of Sterility
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