---
title: "Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx onl... — FDA record D-0777-2023 | Is It on Recall"
description: "Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging."
url: https://isitonrecall.com/recall/fda-drug-d-0777-2023-sodium-chloride-0-9-injection-usp-1000-ml-bags-12-bags-per-carton-rx-only-fresenius-medical-care-nor/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America,... — FDA record D-0777-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
- **Classification**: Class II
- **Recalling firm**: Fresenius Medical Care Holdings, Inc.
- **Quantity**: 53,424 bags
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0777-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0777-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Jun 7, 2023
- **Recall initiation date**: May 23, 2023
- **Center classification date**: Jun 1, 2023
- **Termination date**: May 23, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0777-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Fresenius Medical Care Holdings, Inc. records](https://isitonrecall.com/brand/fresenius-medical-care-holdings-inc/)