# FDA recall D-0372-2025

> **Denver Solutions, LLC DBA Leiters Health** · Class II · drug recall initiated 2025-03-31.

## Product

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,

## Reason for recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

## Distribution

Nationwide in the U.S.A

## Key facts

- **Recall number:** D-0372-2025
- **Recalling firm:** Denver Solutions, LLC DBA Leiters Health
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-31
- **Report date:** 2025-04-30

- **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-0372-2025

## Citation

> AI Analytics. FDA recall D-0372-2025. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0372-2025. Source: US FDA. Licensed CC0.

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