{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077553"
        ],
        "brand_name": [
          "TERCONAZOLE"
        ],
        "generic_name": [
          "TERCONAZOLE"
        ],
        "manufacturer_name": [
          "Cosette Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0713-0552"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "VAGINAL"
        ],
        "substance_name": [
          "TERCONAZOLE"
        ],
        "rxcui": [
          "198245"
        ],
        "spl_id": [
          "513edef8-abb4-1947-e063-6394a90af7bf"
        ],
        "spl_set_id": [
          "38cd1718-6b3c-415d-a17f-7b399adb0ba2"
        ],
        "package_ndc": [
          "0713-0552-73"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175487",
          "M0002083"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "unii": [
          "0KJ2VE664U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89450",
      "recalling_firm": "CARDINAL HEALTHCARE",
      "address_1": "7200 Cardinal Pl W",
      "address_2": "",
      "postal_code": "43017-1094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0198-2024",
      "product_description": "Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only,  Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080.  NDC: 0713-0552-73",
      "product_quantity": "1 unit",
      "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
      "recall_initiation_date": "20220126",
      "center_classification_date": "20231226",
      "termination_date": "20240929",
      "report_date": "20240103",
      "code_info": "Batch 1014228A",
      "more_code_info": ""
    }
  ]
}