{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Xiamen",
      "state": "N/A",
      "country": "China",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "MGC HEALTH"
        ],
        "generic_name": [
          "COUGH DROPS HONEY SUGAR-FREE"
        ],
        "manufacturer_name": [
          "Xiamen Kang Zhongyuan Biotechnology Co., Ltd."
        ],
        "product_ndc": [
          "83698-125"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MENTHOL"
        ],
        "rxcui": [
          "359751"
        ],
        "spl_id": [
          "4deebeae-8aca-d791-e063-6394a90ae31f"
        ],
        "spl_set_id": [
          "23079537-1c06-1373-e063-6394a90a37d2"
        ],
        "package_ndc": [
          "83698-125-25",
          "83698-125-70",
          "3831730000"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L7T10EIP3A"
        ],
        "upc": [
          "383173000085"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98648",
      "recalling_firm": "Xiamen Kang Zhongyuan Biotechnology Co., Ltd.",
      "address_1": "No. 2018",
      "address_2": "2 Jietou Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0461-2026",
      "product_description": "MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085",
      "product_quantity": "N/A",
      "reason_for_recall": "This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.",
      "recall_initiation_date": "20260320",
      "center_classification_date": "20260410",
      "report_date": "20260422",
      "code_info": "Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026."
    }
  ]
}