Product: Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
Reason for recall: cGMP deviations: Temperature excursion during transportation.
Recall initiated: 20250905
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated