Recalls / Class III
Class IIID-0434-2024
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.
- Affected lot / code info
- Lot #: CIC2-23001 A, Exp. 11/30/2026
Why it was recalled
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'.
Recalling firm
- Firm
- X-Gen Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Daniel Zenker Dr, Horseheads, New York 14845-1014
Distribution
- Quantity
- 1332 vials
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-04-02
- FDA classified
- 2024-04-04
- Posted by FDA
- 2024-04-10
- Terminated
- 2025-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0434-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.