# FDA recall D-0445-2023

> **Denver Solutions, LLC DBA Leiters Health** · Class II · drug recall initiated 2023-02-21.

## Product

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94

## Reason for recall

CGMP DEVIATIONS

## Distribution

Nationwide within the United States including VA or other Government facilities

## Key facts

- **Recall number:** D-0445-2023
- **Recalling firm:** Denver Solutions, LLC DBA Leiters Health
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-21
- **Report date:** 2023-03-15
- **Termination date:** 2024-01-11

- **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-0445-2023

## Citation

> AI Analytics. FDA recall D-0445-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0445-2023. Source: US FDA. Licensed CC0.

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