{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA211746"
        ],
        "brand_name": [
          "RYALTRIS"
        ],
        "generic_name": [
          "OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE"
        ],
        "manufacturer_name": [
          "HIKMA SPECIALTY USA INC."
        ],
        "product_ndc": [
          "59467-700"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "OLOPATADINE HYDROCHLORIDE",
          "MOMETASONE FUROATE MONOHYDRATE"
        ],
        "rxcui": [
          "2591806",
          "2591812"
        ],
        "spl_id": [
          "84bec5d6-00c3-45a3-ae2b-ec28c8b9a290"
        ],
        "spl_set_id": [
          "382eac74-a7ce-4f42-ac0a-b253308f335f"
        ],
        "package_ndc": [
          "59467-700-27",
          "59467-700-84"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359467700276"
        ],
        "unii": [
          "2XG66W44KF",
          "MTW0WEG809"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95389",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0006-2025",
      "product_description": "Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.",
      "product_quantity": "45,504 bottles",
      "reason_for_recall": "Defective Delivery System: The dip tube is clogged causing the spray not to work.",
      "recall_initiation_date": "20240924",
      "center_classification_date": "20241003",
      "report_date": "20241009",
      "code_info": "Lots 14230425, Exp Date, Nov-25; 14240024, Exp Date Dec-25; 14240029, Exp Date Dec-25; 14240076, Exp Date Jan-26; 14240082 Exp Date, Jan-26, 14240090, Exp Date Jan-26; and 14240100, Exp Date Jan-26"
    }
  ]
}