# FDA recall D-0116-2024

> **Exela Pharma Sciences LLC** · Class I · drug recall initiated 2023-10-18.

## Product

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.

## Reason for recall

Presence of Particulate Matter: Silicone

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0116-2024
- **Recalling firm:** Exela Pharma Sciences LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-10-18
- **Report date:** 2023-11-29

- **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-0116-2024

## Citation

> AI Analytics. FDA recall D-0116-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/D-0116-2024. Source: US FDA. Licensed CC0.

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