# FDA recall D-0079-2023

> **Exela Pharma Sciences LLC** · Class I · drug recall initiated 2022-11-28.

## Product

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, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.

## Reason for recall

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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0079-2023
- **Recalling firm:** Exela Pharma Sciences LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-11-28
- **Report date:** 2022-12-21
- **Termination date:** 2025-10-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenoir, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0079-2023

## Citation

> AI Analytics. FDA recall D-0079-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0079-2023. Source: US FDA. Licensed CC0.

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