Incorrect Package Insert Prompts Recall

X-Gen Pharmaceuticals Inc. is recalling more than 2500 vials of cyclophosphamide for injection because of an error in the package insert. According to the April 10, 2024, US Food and Drug Administration (FDA) Enforcement Report, the insert lists the concentration of the reconstituted product as 20 mg per vial rather than per mL.

The recall affects the following products, which were distributed throughout the United States:

• cyclophosphamide for injection, 1g/vial, single-dose vial (NDC 39822-0255-01), from lot CIC2-23001 A (Exp. 11/30/26); and
• cyclophosphamide for injection, 500 mg/vial, single-dose vial (NDC 39822-0250-01), from lot CIC1-23001 A (Exp. 8/30/26).

X-Gen Pharmaceuticals voluntarily initiated the recall April 2, 2024. The FDA designated the recall a Class III on April 4, 2024. Per the recall classification, use of the affected product is not likely to cause harm.

Cyclophosphamide is a prescription drug with indications for malignant diseases, including malignant lymphomas, multiple myeloma, and leukemias, as well as for minimal change nephrotic syndrome in pediatric patients.