{
  "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": "81980",
      "recalling_firm": "Mylan Pharmaceuticals Inc.",
      "address_1": "781 Chestnut Ridge Rd",
      "address_2": "",
      "postal_code": "26505-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0424-2019",
      "product_description": "Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.",
      "product_quantity": "10,390 bottles",
      "reason_for_recall": "Defective Container: Potential for broken glass in the neck area of the glass bottles.",
      "recall_initiation_date": "20190201",
      "center_classification_date": "20190204",
      "termination_date": "20190909",
      "report_date": "20190213",
      "code_info": "Lot: GA70535, Exp. April 2019",
      "more_code_info": ""
    }
  ]
}