FDA Drug recall D-0433-2024
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured…
- FDA Drug
- Class III
- terminated
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class III recall of Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured… by X Gen Pharmaceuticals, citing 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 recon….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0433-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-04-02 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | X Gen Pharmaceuticals |
| Distribution | US |
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
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'.
Identifiers
| code_info | Lot #: CIC1-23001 A, Exp. 08/30/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0433-2024%22
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