{
  "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": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021308"
        ],
        "brand_name": [
          "MONISTAT 1 COMBINATION PACK"
        ],
        "generic_name": [
          "MICONAZOLE NITRATE"
        ],
        "manufacturer_name": [
          "Insight Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "63736-013"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "992774",
          "992775",
          "992777",
          "992778",
          "998540",
          "998541"
        ],
        "spl_id": [
          "78e712a2-b8b5-442d-afe5-f603757621d4"
        ],
        "spl_set_id": [
          "97ff1c90-c250-4921-81af-6a56cc9cc7d2"
        ],
        "package_ndc": [
          "63736-013-30"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "70932",
      "recalling_firm": "Medtech Products, Inc.",
      "address_1": "660 White Plains Rd",
      "address_2": "N/A",
      "postal_code": "10591-5139",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1077-2015",
      "product_description": "MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30",
      "product_quantity": "4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples",
      "reason_for_recall": "Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.",
      "recall_initiation_date": "20150410",
      "center_classification_date": "20150513",
      "termination_date": "20160303",
      "report_date": "20150520",
      "code_info": "Lot#: R18193, Exp 10/2016",
      "more_code_info": ""
    }
  ]
}