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
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'.
Classification
Class III
Status
Terminated
Lot
Lot #: CIC2-23001 A, Exp. 11/30/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
X-Gen Pharmaceuticals Inc. — Class III Recall | MedicineWatch US