{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Florham Park",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA079102"
        ],
        "brand_name": [
          "ALTAVERA"
        ],
        "generic_name": [
          "LEVONORGESTREL AND ETHINYL ESTRADIOL"
        ],
        "manufacturer_name": [
          "Xiromed, LLC."
        ],
        "product_ndc": [
          "70700-116"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "238019",
          "748797",
          "748878",
          "1006065"
        ],
        "spl_id": [
          "cd0fbf86-78dd-a8f2-7399-112a042ab767"
        ],
        "spl_set_id": [
          "4701e72b-6378-a771-fb88-1b703031a8bc"
        ],
        "package_ndc": [
          "70700-116-85",
          "70700-116-84"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370700116852"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81044",
      "recalling_firm": "Xiromed LLC",
      "address_1": "180 Florham Park",
      "address_2": "Suite 101",
      "postal_code": "07932",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0016-2019",
      "product_description": "Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)",
      "product_quantity": "40064 3x28  units",
      "reason_for_recall": "Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.",
      "recall_initiation_date": "20180918",
      "center_classification_date": "20181011",
      "termination_date": "20190326",
      "report_date": "20181017",
      "code_info": "Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020",
      "more_code_info": ""
    }
  ]
}