FDA-Drug2025-09-24Class II
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.
Sandoz Inc
Hazard
cGMP deviations: Temperature excursion during transportation.
Sold states
Nationwide in the USA
Affected count
6 vials
Manufactured in
100 College Rd W, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2025Don't want to check this manually?
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