# FDA recall D-0433-2024

> **X-Gen Pharmaceuticals Inc.** · Class III · drug recall initiated 2024-04-02.

## Product

Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.

## Reason for recall

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0433-2024
- **Recalling firm:** X-Gen Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-04-02
- **Report date:** 2024-04-10
- **Termination date:** 2025-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horseheads, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0433-2024

## Citation

> AI Analytics. FDA recall D-0433-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0433-2024. Source: US FDA. Licensed CC0.

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