FDA-Drug2025-04-02Class II
8.4% 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
Exela Pharma Sciences LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide
Affected count
103,950 vials
Manufactured in
1245 Blowing Rock Blvd, N/A, Lenoir, NC, United States
Products
8.4% 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0303-2025Don't want to check this manually?
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