# FDA recall D-0022-2025

> **Fresenius Kabi Compounding, LLC** · Class II · drug recall initiated 2024-09-25.

## Product

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

## Reason for recall

cGMP violations

## Distribution

Product was distributed to 125 direct accounts nationwide.

## Key facts

- **Recall number:** D-0022-2025
- **Recalling firm:** Fresenius Kabi Compounding, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-09-25
- **Report date:** 2024-10-30
- **Termination date:** 2025-08-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2025

## Citation

> AI Analytics. FDA recall D-0022-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0022-2025. Source: US FDA. Licensed CC0.

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