FDARecalled Sep 24, 2025 · #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, P...
Hazard
Class II — temporary health risk
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cGMP deviations: Temperature excursion during transportation. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Sandoz Inc
- Model numbers
- 110459
- UPCs
- 00307813528104, 10686040629319, 10687281435306, 10687409963168, 10701200331212, 10687325644911, 10687661160169