{
  "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": "Terminated",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "CAPSAICIN"
        ],
        "generic_name": [
          "CAPSAICIN"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-195"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CAPSAICIN"
        ],
        "rxcui": [
          "198555"
        ],
        "spl_id": [
          "47e30136-9a43-81c5-e063-6394a90a3fbc"
        ],
        "spl_set_id": [
          "ef5a3846-1d2f-7023-e053-2a95a90ad716"
        ],
        "package_ndc": [
          "50268-195-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "S07O44R1ZM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92868",
      "recalling_firm": "AVKARE LLC",
      "address_1": "615 N 1st St",
      "address_2": "N/A",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Affected product was distributed to nineteen (19) consignees within the united states.",
      "recall_number": "D-1147-2023",
      "product_description": "Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478",
      "product_quantity": "35,184 cartons",
      "reason_for_recall": "Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste",
      "recall_initiation_date": "20230811",
      "center_classification_date": "20230907",
      "termination_date": "20240429",
      "report_date": "20230913",
      "code_info": "Lot # P22078; Exp. 11/30/2024"
    }
  ]
}