X-Gen Pharmaceuticals Inc.

FDA Class III Recall: X-Gen Pharmaceuticals' Cyclophosphamide Labeling Error Impacts Oncology Supply

X-Gen Pharmaceuticals Inc. initiated a Class III recall (D-0434-2024) for 1332 vials of Cyclophosphamide for Injection, USP, due to a critical labeling error. The package insert incorrectly stated the reconstituted product's concentration as '20 mg per vial' instead of '20 mg per mL'. This event underscores the imperative for robust quality control in pharmaceutical labeling, directly impacting patient safety and supply chain integrity.