# FDA recall D-0075-2023

> **Fresenius Medical Care Holdings, Inc.** · Class II · drug recall initiated 2022-11-22.

## Product

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

## Reason for recall

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

## Distribution

Product was distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0075-2023
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-11-22
- **Report date:** 2022-12-14

- **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-0075-2023

## Citation

> AI Analytics. FDA recall D-0075-2023. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0075-2023. Source: US FDA. Licensed CC0.

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