---
title: "Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... — FDA record D-0364-2023 | Is It on Recall"
description: "CGMP Deviations: Potential product carryover."
url: https://isitonrecall.com/recall/fda-drug-d-0364-2023-sterile-water-for-injection-usp-30x5-ml-single-dose-vials-rx-only-nephron-4500-12th-street-extension/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbi... — FDA record D-0364-2023

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 Feb 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**: Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
- **Reason**: CGMP Deviations: Potential product carryover.
- **Classification**: Class II
- **Recalling firm**: Nephron Sc Inc
- **Quantity**: 325,080 vials
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0364-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0364-2023%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 #: 224011, 224021, 224022, 224023 Exp 12/31/2023 |

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

## Distribution

United States

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Mar 8, 2023
- **Recall initiation date**: Feb 23, 2023
- **Center classification date**: Mar 1, 2023
- **Termination date**: Oct 11, 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-0364-2023%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/) [Nephron Sc Inc records](https://isitonrecall.com/brand/nephron-sc-inc/)