# FDA recall D-0117-2024

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

## Product

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).

## Reason for recall

Presence of Particulate Matter: Silicone

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0117-2024
- **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-0117-2024

## Citation

> MORVS. FDA recall D-0117-2024. Retrieved 2026-10-17 from https://api.morvs.ai/recall/D-0117-2024. Source: US FDA. Licensed CC0.

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