# FDA recall D-0777-2023

> **Fresenius Medical Care Holdings, Inc.** · Class II · drug recall initiated 2023-05-23.

## Product

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

## Reason for recall

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

## Distribution

Product was distributed to 32 clinics in SC, NC and VA.

## Key facts

- **Recall number:** D-0777-2023
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-23
- **Report date:** 2023-06-07
- **Termination date:** 2024-05-23

- **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-0777-2023

## Citation

> AI Analytics. FDA recall D-0777-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0777-2023. Source: US FDA. Licensed CC0.

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