FDAFDA · Food and drugs·Recall number D-0651-2025
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.
Published September 24, 2025 · Recall initiated: September 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Temperature excursion during transportation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CYCLOPHOSPHAMIDE
- Manufacturer
- Sandoz Inc
- Distributor
- Nationwide in the USA
- UPC
- 106872814353
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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