Recalls / Class II
Class IID-0651-2025
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.
- Brand name
- Cyclophosphamide
- Generic name
- Cyclophosphamide
- Active ingredient
- Cyclophosphamide
- Route
- Intravenous
- NDCs
- 0781-3528, 0781-3529, 0781-3530
- FDA application
- NDA217150
- Affected lot / code info
- 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
Why it was recalled
cGMP deviations: Temperature excursion during transportation.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, N/A, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 6 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-09-05
- FDA classified
- 2025-09-15
- Posted by FDA
- 2025-09-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0651-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.