{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076242"
        ],
        "brand_name": [
          "CALCITRIOL"
        ],
        "generic_name": [
          "CALCITRIOL"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-3120"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CALCITRIOL"
        ],
        "rxcui": [
          "313932"
        ],
        "spl_id": [
          "2b8745f3-5289-474e-bd44-48b59a40dd78"
        ],
        "spl_set_id": [
          "3289b482-8733-484d-b1db-d7f4cdcd1ac2"
        ],
        "package_ndc": [
          "0054-3120-41"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0004229",
          "N0000175908"
        ],
        "pharm_class_cs": [
          "Cholecalciferol [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin D3 Analog [EPC]"
        ],
        "unii": [
          "FXC9231JVH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68389",
      "recalling_firm": "Boehringer Ingelheim Roxane Inc",
      "address_1": "1809 Wilson Rd",
      "address_2": "",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1427-2014",
      "product_description": "Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.",
      "product_quantity": "5364 bottles",
      "reason_for_recall": "Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point",
      "recall_initiation_date": "20140501",
      "center_classification_date": "20140709",
      "termination_date": "20150401",
      "report_date": "20140716",
      "code_info": "Lot # 360122A, EXP Date: MAY 2015",
      "more_code_info": ""
    }
  ]
}