{
  "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": "North Wales",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA075863"
        ],
        "brand_name": [
          "KARIVA"
        ],
        "generic_name": [
          "DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0555-9050"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "248310",
          "249357",
          "748797",
          "759743",
          "762001"
        ],
        "spl_id": [
          "ad406427-c901-4f7c-9b4f-68bd0667593d"
        ],
        "spl_set_id": [
          "7b11e11f-6977-4109-b9bd-a066e5d1278a"
        ],
        "package_ndc": [
          "0555-9050-79",
          "0555-9050-58"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "68610",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "1090 Horsham Rd",
      "address_2": "N/A",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1438-2014",
      "product_description": "Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets    0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only,  Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58",
      "product_quantity": "1125 blister packs",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: out of specification impurity test results.",
      "recall_initiation_date": "20140617",
      "center_classification_date": "20140717",
      "termination_date": "20150309",
      "report_date": "20140723",
      "code_info": "Lot 33805325A, Exp.11/14"
    }
  ]
}