{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA217150"
        ],
        "brand_name": [
          "CYCLOPHOSPHAMIDE"
        ],
        "generic_name": [
          "CYCLOPHOSPHAMIDE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-3528",
          "0781-3529",
          "0781-3530"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CYCLOPHOSPHAMIDE"
        ],
        "rxcui": [
          "2679073"
        ],
        "spl_id": [
          "3a7a4ad7-90ca-4d84-92f1-c61032067deb"
        ],
        "spl_set_id": [
          "cf2f4b95-0327-499a-a5a3-51b1bdef68c5"
        ],
        "package_ndc": [
          "0781-3528-75",
          "0781-3528-10",
          "0781-3529-70",
          "0781-3529-10",
          "0781-3530-80",
          "0781-3530-10",
          "0030781352",
          "1068604062",
          "1068728143",
          "1068740996",
          "1070120033",
          "1068732564",
          "1068766116"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8N3DW7272P"
        ],
        "upc": [
          "106872814353"
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      },
      "product_type": "Drugs",
      "event_id": "97549",
      "recalling_firm": "Sandoz Inc",
      "address_1": "100 College Rd W",
      "address_2": "N/A",
      "postal_code": "08540-6604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "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.",
      "product_quantity": "6 vials",
      "reason_for_recall": "cGMP deviations: Temperature excursion during transportation.",
      "recall_initiation_date": "20250905",
      "center_classification_date": "20250915",
      "report_date": "20250924",
      "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"
    }
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}