{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New Paltz",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "brand_name": [
          "CYSTEX"
        ],
        "generic_name": [
          "METHENAMINE, SODIUM SALICYLATE"
        ],
        "manufacturer_name": [
          "Clarion Brands, LLC"
        ],
        "product_ndc": [
          "69693-512"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHENAMINE",
          "SODIUM SALICYLATE"
        ],
        "rxcui": [
          "1489932",
          "1489934"
        ],
        "spl_id": [
          "485b5018-57ed-90d7-e063-6294a90ae5e2"
        ],
        "spl_set_id": [
          "62200228-be42-1cda-9493-02bb491537c8"
        ],
        "package_ndc": [
          "69693-512-40",
          "69693-512-20",
          "69693-512-24",
          "69693-512-48"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0889476512480"
        ],
        "unii": [
          "J50OIX95QV",
          "WIQ1H85SYP"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89464",
      "recalling_firm": "Ultra Seal Corporation",
      "address_1": "521 Main St",
      "address_2": "N/A",
      "postal_code": "12561-1609",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0471-2022",
      "product_description": "Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40",
      "product_quantity": "a) 702,240 blisters, b) 30,180 blisters",
      "reason_for_recall": "cGMP deviations",
      "recall_initiation_date": "20220124",
      "center_classification_date": "20220131",
      "termination_date": "20231016",
      "report_date": "20220209",
      "code_info": "Lot #: a) 19A043, 19A093, Exp. Date 01/2022; 19B062,19C079,19C080, Exp. Date 03/2022; 19D041, Exp. Date 04/2022; 19E035, 19E087, Exp. Date 05/2022; 19G084, Exp. Date 08/2022; 19H098, Exp. Date 09/2022  b) 19H098A, Exp. Date 09/2022"
    }
  ]
}