# FDA recall D-0827-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · drug recall initiated 2017-11-13.

## Product

0.9% Sodium Chloride  Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Product was distributed throughout the United States.

## Key facts

- **Recall number:** D-0827-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-13
- **Report date:** 2018-05-30
- **Termination date:** 2018-12-06

- **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-0827-2018

## Citation

> AI Analytics. FDA recall D-0827-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0827-2018. Source: US FDA. Licensed CC0.

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