Recall D-0303-2025

US Class II Ongoing · initiated 2025-03-07

Recalling firm

Exela Pharma Sciences LLC, NC

Product

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

Reason for recall

Lack of Assurance of Sterility

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