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8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufacture...

FDA Recall #D-0369-2022 — Class II — January 11, 2022

Recall #D-0369-2022 Date: January 11, 2022 Classification: Class II Status: Terminated

Product Description

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1

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

18,960 vials

Distribution

Nationwide within the United States

Code Information

Lot #: C0001088/P0001317, Exp. Date 08/2023

Status

Terminated

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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