WhichRecall
Class IIReported 2025-04-02

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

Recalled by Exela Pharma Sciences LLC

Reason for Recall

Lack of Assurance of Sterility

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Recall Number
D-0303-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-03-07
Reported
2025-04-02
Distribution
Nationwide
Code Info
Lots: 10006417 and 10006418, Exp. 11/30/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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