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

FDA Recall #D-0080-2023 — Class I — November 28, 2022

Recall #D-0080-2023 Date: November 28, 2022 Classification: Class I Status: Terminated

Product Description

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

Reason for Recall

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Recalling Firm

Exela Pharma Sciences LLC — Lenoir, NC

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

37,320 vials

Distribution

Nationwide within the United States

Code Information

Lot: P0001490 Exp. 12/2023

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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