Home / Recalls / Sandoz Inc / D-0651-2025

D-0651-2025 Class II Ongoing

Recalled by Sandoz Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
September 24, 2025
Initiation Date
September 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 vials

Product Description

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.

Distribution Pattern

Nationwide in the USA

Code Information

Only the following 6 GTN Numbers for Lot # 110459 exp. date 02/28/2027: (01)00307813528104(21)10686040629319 (01)00307813528104(21)10687281435306 (01)00307813528104(21)10687409963168 (01)00307813528104(21)10701200331212 (01)00307813528104(21)10687325644911 (01)00307813528104(21)10687661160169

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