{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202828"
        ],
        "brand_name": [
          "ZOLEDRONIC ACID"
        ],
        "generic_name": [
          "ZOLEDRONIC ACID"
        ],
        "manufacturer_name": [
          "Sagent Pharmaceuticals"
        ],
        "product_ndc": [
          "25021-830"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ZOLEDRONIC ACID"
        ],
        "rxcui": [
          "705824"
        ],
        "spl_id": [
          "dd7663fa-8a03-4717-a3fb-c4c03e6300e8"
        ],
        "spl_set_id": [
          "164500d7-51cf-438a-8bee-7a7dce76ad7a"
        ],
        "package_ndc": [
          "25021-830-82",
          "25021-830-87"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "6XC1PAD3KF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67689",
      "recalling_firm": "Sagent Pharmaceuticals Inc",
      "address_1": "1901 N Roselle Rd Ste 700",
      "address_2": "N/A",
      "postal_code": "60195-3194",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1615-2014",
      "product_description": "Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82",
      "product_quantity": "10,622 bags",
      "reason_for_recall": "Lack of Assurance of Sterility; leaking of premix bags",
      "recall_initiation_date": "20140304",
      "center_classification_date": "20140929",
      "termination_date": "20160707",
      "report_date": "20141008",
      "code_info": "NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015."
    }
  ]
}