X-Gen Pharmaceuticals Inc. is recalling 2,615 vials of Cyclophosphamide for Injection, USP, in 500mg and 1g strengths. The recall was initiated because the Package Insert incorrectly lists the concentration of the prepared medication as "20 mg per vial" instead of the correct "20 mg per mL." Cyclophosphamide is a chemotherapy medication used for intravenous treatment.
The error in the concentration instructions could lead to incorrect preparation of the drug by healthcare providers, resulting in a lower dose being administered than intended. This underdosing could reduce the effectiveness of the treatment for patients.
Recall #: D-0433-2024; Quantity: 1283 vials
Recall #: D-0434-2024; Quantity: 1332 vials
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Sources: FDA iRES · Raw API Response
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