{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA018044"
        ],
        "brand_name": [
          "CALCITRIOL"
        ],
        "generic_name": [
          "CALCITRIOL"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "63304-239",
          "63304-240",
          "63304-241"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CALCITRIOL"
        ],
        "rxcui": [
          "308867",
          "308868",
          "313932"
        ],
        "spl_id": [
          "ccc0e02b-bd1e-45f2-9256-6933ac193518"
        ],
        "spl_set_id": [
          "66a69351-5b09-4368-a9fa-acf81b5ad882"
        ],
        "package_ndc": [
          "63304-239-30",
          "63304-239-01",
          "63304-240-01",
          "63304-241-59"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363304239010",
          "0363304240016"
        ],
        "nui": [
          "M0004229",
          "N0000175908"
        ],
        "pharm_class_cs": [
          "Cholecalciferol [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin D3 Analog [EPC]"
        ],
        "unii": [
          "FXC9231JVH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80326",
      "recalling_firm": "Validus Pharmaceuticals, Inc.",
      "address_1": "119 Cherry Hill Rd Ste 310",
      "address_2": "N/A",
      "postal_code": "07054-1126",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. nationwide",
      "recall_number": "D-1170-2018",
      "product_description": "Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59",
      "product_quantity": "7864 bottles",
      "reason_for_recall": "Subpotency: lower than expected potency result was obtained at the 18 month stability time point.",
      "recall_initiation_date": "20180615",
      "center_classification_date": "20180905",
      "termination_date": "20210122",
      "report_date": "20180905",
      "code_info": "RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019"
    }
  ]
}