{
  "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": [
          "NDA021544"
        ],
        "brand_name": [
          "JOLESSA"
        ],
        "generic_name": [
          "LEVONORGESTREL / ETHINYL ESTRADIOL"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0555-9123"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "238019",
          "748797",
          "751901",
          "762663"
        ],
        "spl_id": [
          "aaf5797d-3069-42ba-a8d2-088e5cd33b2c"
        ],
        "spl_set_id": [
          "f1076019-6f2c-4c90-9f3c-ab0c7cdd9315"
        ],
        "package_ndc": [
          "0555-9123-66"
        ],
        "is_original_packager": [
          true
        ]
      },
      "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-683-2013",
      "product_description": "Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66",
      "product_quantity": "54,412 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 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013."
    }
  ]
}