# FDA recall D-0178-2023

> **Nephron Sc Inc** · Class II · drug recall initiated 2023-01-12.

## Product

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.

## Reason for recall

CGMP Deviations: potential for trace amounts of product carryover.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0178-2023
- **Recalling firm:** Nephron Sc Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-01-12
- **Report date:** 2023-02-01
- **Termination date:** 2024-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Columbia, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0178-2023

## Citation

> AI Analytics. FDA recall D-0178-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0178-2023. Source: US FDA. Licensed CC0.

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