Drug recall D-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.
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'.
Lots and codes
Lot #: CIC2-23001 A, Exp. 11/30/2026
Recall details
- Recalling firm
- X-Gen Pharmaceuticals Inc., Horseheads, NY
- Quantity
- 1332 vials
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 2, 2024
- Terminated
- September 30, 2025
Related products
- NDC 39822-0255 Cyclophosphamide · Cyclophosphamide 1 g/50mL · XGen Pharmaceuticals DJB, Inc.