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D-0303-2025 Class II Ongoing

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

FDA drug recall D-0303-2025 was initiated by Exela Pharma Sciences LLC on Mar 7, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 103,950 vials.

Recall Details

Product Type: Drugs
Report Date: Apr 2, 2025
Initiation Date: Mar 7, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 103,950 vials

Product Description

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

Distribution Pattern

Nationwide

Code Information

Lots: 10006417 and 10006418, Exp. 11/30/2026

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0303-2025
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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D-0023-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose… (Oct 4, 2022)
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D-1585-2020 Class III — Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx… (May 5, 2020)