{
  "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": [
    {
      "country": "United States",
      "city": "Princeton",
      "address_1": "107 College Rd E",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: OOS for unknown impurities.",
      "address_2": "",
      "product_quantity": "10,530 vials",
      "code_info": "Batch Numbers: BS704, EXP 12/018;  BS725, EXP 6/2019; BS745, EXP 11/2019.",
      "center_classification_date": "20181026",
      "distribution_pattern": "Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.",
      "state": "NJ",
      "product_description": "Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11",
      "report_date": "20181003",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA091363"
        ],
        "brand_name": [
          "ZOLEDRONIC ACID"
        ],
        "generic_name": [
          "ZOLEDRONIC ACID"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Inc"
        ],
        "product_ndc": [
          "43598-331"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ZOLEDRONIC ACID"
        ],
        "rxcui": [
          "705824"
        ],
        "spl_id": [
          "d89899a3-8ada-0438-07b9-2164c640995a"
        ],
        "spl_set_id": [
          "c8e02635-4473-8ba2-248f-ced58dbeabce"
        ],
        "package_ndc": [
          "43598-331-11"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "6XC1PAD3KF"
        ]
      },
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "recall_number": "D-0104-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "81012",
      "termination_date": "20200303",
      "more_code_info": "",
      "recall_initiation_date": "20180912",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}