{
  "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": "Santa Rosa",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "SINUFRIN QUICK RELIEF DECONGESTANT"
        ],
        "generic_name": [
          "SINUFRIN"
        ],
        "manufacturer_name": [
          "Neilmed pharmaceuticals Inc."
        ],
        "product_ndc": [
          "13709-325"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "OXYMETAZOLINE"
        ],
        "spl_id": [
          "0e913859-1a68-3915-e063-6394a90a7e63"
        ],
        "spl_set_id": [
          "0c36a34e-462d-713c-e063-6294a90a1776"
        ],
        "package_ndc": [
          "13709-325-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000192562",
          "N0000009908",
          "N0000175651",
          "M0461078"
        ],
        "pharm_class_epc": [
          "Vasoconstrictor [EPC]"
        ],
        "pharm_class_pe": [
          "Vasoconstriction [PE]",
          "Increased Sympathetic Activity [PE]"
        ],
        "pharm_class_cs": [
          "Imidazolines [CS]"
        ],
        "unii": [
          "8VLN5B44ZY"
        ],
        "upc": [
          "705928090019"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94853",
      "recalling_firm": "Neilmed Pharmaceuticals Inc",
      "address_1": "601 Aviation Blvd",
      "address_2": "",
      "postal_code": "95403-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0569-2024",
      "product_description": "SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.",
      "product_quantity": "20,370 bottles",
      "reason_for_recall": "Sub-potent Drug",
      "recall_initiation_date": "20240624",
      "center_classification_date": "20240628",
      "report_date": "20240703",
      "code_info": "Lot: SD134; Exp: 10/31/2026",
      "more_code_info": ""
    }
  ]
}