# FDA recall D-0490-2025

> **Fresenius Medical Care Holdings, Inc.** · Class II · drug recall initiated 2025-05-27.

## Product

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0490-2025
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-27
- **Report date:** 2025-07-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2025

## Citation

> AI Analytics. FDA recall D-0490-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0490-2025. Source: US FDA. Licensed CC0.

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