# FDA recall D-0278-2024

> **Denver Solutions, LLC DBA Leiters Health** · Class I · drug recall initiated 2023-12-28.

## Product

FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.

## Reason for recall

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0278-2024
- **Recalling firm:** Denver Solutions, LLC DBA Leiters Health
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-12-28
- **Report date:** 2024-02-07

- **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-0278-2024

## Citation

> AI Analytics. FDA recall D-0278-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0278-2024. Source: US FDA. Licensed CC0.

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