{
  "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": "Sellersville",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA076380"
        ],
        "brand_name": [
          "JUNEL"
        ],
        "generic_name": [
          "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0555-9025",
          "0555-9026",
          "0555-9027",
          "0555-9028"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ETHINYL ESTRADIOL",
          "NORETHINDRONE ACETATE"
        ],
        "rxcui": [
          "259176",
          "1358762",
          "1358763",
          "1358765",
          "1358776",
          "1358780",
          "1359022",
          "1359023",
          "1359025",
          "1359028",
          "1359030"
        ],
        "spl_id": [
          "254f2e35-bbeb-4134-8799-2d3fa959fe84"
        ],
        "spl_set_id": [
          "8b82ad14-580c-4145-b825-dce849f95363"
        ],
        "package_ndc": [
          "0555-9025-42",
          "0555-9026-58",
          "0555-9027-42",
          "0555-9028-58"
        ],
        "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": "64644",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc.",
      "address_1": "650 Cathill Rd",
      "address_2": "N/A",
      "postal_code": "18960-1512",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution.  No foreign or government accounts.",
      "recall_number": "D-682-2013",
      "product_description": "Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58",
      "product_quantity": "47,200 blister packs",
      "reason_for_recall": "Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing",
      "recall_initiation_date": "20130315",
      "center_classification_date": "20130705",
      "termination_date": "20140410",
      "report_date": "20130717",
      "code_info": "NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013."
    }
  ]
}