{
  "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": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA202771"
        ],
        "brand_name": [
          "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL"
        ],
        "generic_name": [
          "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-7280"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ETHINYL ESTRADIOL",
          "NORETHINDRONE ACETATE"
        ],
        "rxcui": [
          "1358762",
          "1358776"
        ],
        "spl_id": [
          "e450353d-021c-b48d-d1ea-0787a1561ae2"
        ],
        "spl_set_id": [
          "89948751-bd6e-4e9c-b87c-8782706c1097"
        ],
        "package_ndc": [
          "0378-7280-85",
          "0378-7280-53"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175825",
          "N0000000100"
        ],
        "pharm_class_epc": [
          "Estrogen [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Agonists [MoA]"
        ],
        "unii": [
          "423D2T571U",
          "9S44LIC7OJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77065",
      "recalling_firm": "Mylan Pharmaceuticals Inc.",
      "address_1": "781 Chestnut Ridge Rd",
      "address_2": "",
      "postal_code": "26505-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in USA",
      "recall_number": "D-0861-2017",
      "product_description": "Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV  26505 U.S.A., Made in India.",
      "product_quantity": "8,605 cartons",
      "reason_for_recall": "Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.",
      "recall_initiation_date": "20170130",
      "center_classification_date": "20170523",
      "termination_date": "20170601",
      "report_date": "20170531",
      "code_info": "Lot #: 6327A006, Exp 02/18",
      "more_code_info": ""
    }
  ]
}