{
  "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": "Wilson",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022003"
        ],
        "brand_name": [
          "NOXAFIL"
        ],
        "generic_name": [
          "POSACONAZOLE"
        ],
        "manufacturer_name": [
          "Merck Sharp & Dohme LLC"
        ],
        "product_ndc": [
          "0085-1328",
          "0085-4324",
          "0085-4331",
          "0085-2224"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POSACONAZOLE"
        ],
        "rxcui": [
          "665019",
          "665022",
          "1482908",
          "1482912",
          "1492043",
          "1492047",
          "2558603",
          "2558607"
        ],
        "spl_id": [
          "56740f7d-3b29-4786-b5c7-eea6c0f14400"
        ],
        "spl_set_id": [
          "b073b082-7b57-4423-8c06-4fd4263d6f84"
        ],
        "package_ndc": [
          "0085-1328-01",
          "0085-4324-02",
          "0085-4331-01",
          "0085-2224-01",
          "0085-2224-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300854324025"
        ],
        "nui": [
          "N0000175487",
          "M0002083"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "unii": [
          "6TK1G07BHZ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98113",
      "recalling_firm": "Merck Sharp & Dohme LLC",
      "address_1": "4633 Merck Rd W",
      "address_2": "N/A",
      "postal_code": "27893-9613",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0242-2026",
      "product_description": "Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.",
      "product_quantity": "845 kits",
      "reason_for_recall": "Presence of particulate matter: potential presence of metal particulates in the product.",
      "recall_initiation_date": "20251212",
      "center_classification_date": "20251223",
      "report_date": "20251231",
      "code_info": "Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026"
    }
  ]
}