# FDA recall D-0357-2023

> **Nephron Sterile Compounding Center LLC** · Class II · drug recall initiated 2023-02-22.

## Product

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0357-2023
- **Recalling firm:** Nephron Sterile Compounding Center LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-22
- **Report date:** 2023-03-08
- **Termination date:** 2024-09-24

- **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-0357-2023

## Citation

> AI Analytics. FDA recall D-0357-2023. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0357-2023. Source: US FDA. Licensed CC0.

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