{
  "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": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA202236"
        ],
        "brand_name": [
          "DYMISTA"
        ],
        "generic_name": [
          "AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE"
        ],
        "manufacturer_name": [
          "Viatris Specialty LLC"
        ],
        "product_ndc": [
          "0037-0245"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "AZELASTINE HYDROCHLORIDE",
          "FLUTICASONE PROPIONATE"
        ],
        "rxcui": [
          "1797847",
          "1797849"
        ],
        "spl_id": [
          "ed1f7ce9-ccfa-4e73-940f-14ea8166d524"
        ],
        "spl_set_id": [
          "4c557ec4-c4cf-11df-851a-0800200c9a66"
        ],
        "package_ndc": [
          "0037-0245-23"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0L591QR10I",
          "O2GMZ0LF5W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77850",
      "recalling_firm": "Mylan Pharmaceuticals Inc.",
      "address_1": "781 Chestnut Ridge Rd",
      "address_2": "N/A",
      "postal_code": "26505-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-1075-2018",
      "product_description": "Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only,  Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23",
      "product_quantity": "20,780 bottles",
      "reason_for_recall": "Presence of foreign substance: Potential for glass in the neck area of the glass bottles.",
      "recall_initiation_date": "20180725",
      "center_classification_date": "20180809",
      "termination_date": "20190815",
      "report_date": "20180815",
      "code_info": "Lot #: GA70246, GA70254, Exp 02/2019"
    }
  ]
}