{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091363"
        ],
        "brand_name": [
          "ZOLEDRONIC ACID"
        ],
        "generic_name": [
          "ZOLEDRONIC ACID"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Ltd"
        ],
        "product_ndc": [
          "55111-688"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ZOLEDRONIC ACID"
        ],
        "rxcui": [
          "705824"
        ],
        "spl_id": [
          "251add88-5c4f-2750-c713-744fcf3a60ba"
        ],
        "spl_set_id": [
          "f94a5c9e-74bc-d09e-cd65-394b2a5de2ad"
        ],
        "package_ndc": [
          "55111-688-52"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111688525"
        ],
        "unii": [
          "6XC1PAD3KF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73527",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0784-2016",
      "product_description": "Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA   NDC 55111-688-52",
      "product_quantity": "3,342 vials",
      "reason_for_recall": "Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial",
      "recall_initiation_date": "20160303",
      "center_classification_date": "20160328",
      "termination_date": "20170503",
      "report_date": "20160406",
      "code_info": "Lot BS523, exp 10/2017"
    }
  ]
}