{
  "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": "Tokyo",
      "state": "N/A",
      "country": "Japan",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M001"
        ],
        "brand_name": [
          "INON ACE"
        ],
        "generic_name": [
          "MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE"
        ],
        "manufacturer_name": [
          "Sato Pharmaceutical Co., Ltd."
        ],
        "product_ndc": [
          "49873-402"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MAGNESIUM HYDROXIDE",
          "SILODRATE",
          "DIMETHICONE"
        ],
        "rxcui": [
          "1235450",
          "1235456"
        ],
        "spl_id": [
          "09d87d9c-fe4c-fd02-e063-6394a90a56bd"
        ],
        "spl_set_id": [
          "0af4355f-e160-409d-8471-2de98dbc6f7c"
        ],
        "package_ndc": [
          "49873-402-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349873402017"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "NBZ3QY004S",
          "9T3UU8T0QK",
          "92RU3N3Y1O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98216",
      "recalling_firm": "Sato Pharmaceutical Co., Ltd",
      "address_1": "Ahc Building 1-5-27",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "CA and HI",
      "recall_number": "D-0298-2026",
      "product_description": "INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01",
      "product_quantity": "3,640 bottles",
      "reason_for_recall": "Failed Disintegration Specifications: above the time expected.",
      "recall_initiation_date": "20251219",
      "center_classification_date": "20260127",
      "report_date": "20260204",
      "code_info": "Lot#: PWXT, Exp 1/31/2027"
    }
  ]
}