# FDA recall D-0363-2024

> **Denver Solutions, LLC DBA Leiters Health** · Class II · drug recall initiated 2024-02-20.

## Product

Lidocaine HCL 1% (10mg/mL),  PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

## Reason for recall

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0363-2024
- **Recalling firm:** Denver Solutions, LLC DBA Leiters Health
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-02-20
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Englewood, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0363-2024

## Citation

> AI Analytics. FDA recall D-0363-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0363-2024. Source: US FDA. Licensed CC0.

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