Cyclophosphamide for Injection — Class III drug recall D-0434-2024
Terminated recall by X-Gen Pharmaceuticals Inc., reported 2024-04-10, distributed nationwide. Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Prep
| Recall number | D-0434-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-Gen Pharmaceuticals Inc., Horseheads, NY, United States |
| Recall initiated | 2024-04-02 |
| Classified | 2024-04-04 |
| Reported by FDA | 2024-04-10 |
| Terminated | 2025-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,332 vials |
| Reason classes | labeling |
| NDC | 39822-0255-01 |
| Lot numbers | CIC2-23001A |
| Expiration dates | 2026-11-30 |
Product
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.
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'.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0434-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.