{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Monroe Township",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "M001"
        ],
        "brand_name": [
          "E-Z-GAS"
        ],
        "generic_name": [
          "ANTACID/ANTIFLATULENT"
        ],
        "manufacturer_name": [
          "E-Z-EM, INC."
        ],
        "product_ndc": [
          "10361-793"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ANHYDROUS CITRIC ACID",
          "DIMETHICONE",
          "SILICON DIOXIDE",
          "SODIUM BICARBONATE"
        ],
        "spl_id": [
          "cee80987-94f6-6f1e-d2eb-45a137ec874d"
        ],
        "spl_set_id": [
          "4e12e1cb-b033-076d-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "10361-793-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175833",
          "N0000175835",
          "N0000175980",
          "N0000008556",
          "N0000175089",
          "N0000010282"
        ],
        "pharm_class_moa": [
          "Acidifying Activity [MoA]",
          "Calcium Chelating Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Calculi Dissolution Agent [EPC]",
          "Anti-coagulant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Coagulation Factor Activity [PE]",
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "XF417D3PSL",
          "92RU3N3Y1O",
          "ETJ7Z6XBU4",
          "8MDF5V39QO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69389",
      "recalling_firm": "Bracco Diagnostic Inc",
      "address_1": "259 Prospect Plains Road",
      "address_2": "Building H",
      "postal_code": "08831",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0014-2015",
      "product_description": "E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured  in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409   NDC 10361-793-01",
      "product_quantity": "58,050 packets",
      "reason_for_recall": "Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.",
      "recall_initiation_date": "20140918",
      "center_classification_date": "20141009",
      "termination_date": "20150630",
      "report_date": "20141015",
      "code_info": "Lot # F12C01; Exp. 02/15",
      "more_code_info": ""
    }
  ]
}