{
  "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 III",
      "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": "81012",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.",
      "recall_number": "D-0103-2019",
      "product_description": "Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52",
      "product_quantity": "59,468 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: OOS for unknown impurities.",
      "recall_initiation_date": "20180912",
      "center_classification_date": "20181026",
      "termination_date": "20200303",
      "report_date": "20181003",
      "code_info": "Batch Numbers: BS633, EXP 9/2018; BS701, BS702, BS703, EXP 12/2018; BS708, BS709, BS711, BS712, BS713, BS714, BS715, EXP 3/2019; BS726, BS727, EXP 6/2019; BS728, BS729, BS730, EXP 7/2019; BS801, EXP 03/2020..",
      "more_code_info": ""
    }
  ]
}