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8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per...

FDA Recall #D-0303-2025 — Class II — March 7, 2025

Recall #D-0303-2025 Date: March 7, 2025 Classification: Class II Status: Ongoing

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

Recalling Firm

Exela Pharma Sciences LLC — Lenoir, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

103,950 vials

Distribution

Nationwide

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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