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.
Reported: September 24, 2025 Initiated: September 5, 2025 #D-0651-2025
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.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 6 vials
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sandoz Inc. Units affected: 6 vials.
Why was this product recalled? ▼
cGMP deviations: Temperature excursion during transportation.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2025. Severity: Moderate. Recall number: D-0651-2025.
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