# FDA recall D-0409-2025

> **Apollo Care, LLC** · Class II · drug recall initiated 2025-04-15.

## Product

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25

## Reason for recall

Lack of Assurance of Sterility

## Distribution

MO

## Key facts

- **Recall number:** D-0409-2025
- **Recalling firm:** Apollo Care, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-15
- **Report date:** 2025-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbia, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0409-2025

## Citation

> AI Analytics. FDA recall D-0409-2025. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0409-2025. Source: US FDA. Licensed CC0.

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