Drug Enforcement D-0651-2025

cGMP deviations: Temperature excursion during transportation.

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

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Product Information

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.
Product quantity
263 vials
Reason for recall
cGMP deviations: Temperature excursion during transportation.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Sandoz Inc
Address
100 College Rd W, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0651-2025
Event ID
97549
Recall initiation date
September 5, 2025
Center classification date
September 15, 2025
Code info
Lot # 110459 exp. date 02/28/2027
More code info
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