{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040597"
        ],
        "brand_name": [
          "BENZONATATE"
        ],
        "generic_name": [
          "BENZONATATE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "68084-214"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BENZONATATE"
        ],
        "rxcui": [
          "197397"
        ],
        "spl_id": [
          "235a2641-ce68-1f9c-e063-6394a90ac8a7"
        ],
        "spl_set_id": [
          "9a71725a-64b6-4800-a79c-aa4b2d74d44f"
        ],
        "package_ndc": [
          "68084-214-11",
          "68084-214-01"
        ],
        "original_packager_product_ndc": [
          "68382-247"
        ],
        "nui": [
          "N0000009010",
          "N0000175796"
        ],
        "pharm_class_pe": [
          "Decreased Tracheobronchial Stretch Receptor Activity [PE]"
        ],
        "pharm_class_epc": [
          "Non-narcotic Antitussive [EPC]"
        ],
        "unii": [
          "5P4DHS6ENR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70320",
      "recalling_firm": "American Health Packaging",
      "address_1": "2550 John Glenn Ave",
      "address_2": "Suite A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0430-2015",
      "product_description": "Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)",
      "product_quantity": "2284 cartons (100 individual unit doses per carton)",
      "reason_for_recall": "Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules",
      "recall_initiation_date": "20150106",
      "center_classification_date": "20150401",
      "termination_date": "20150723",
      "report_date": "20150408",
      "code_info": "AHP lot number 145513, exp 6/2016"
    }
  ]
}