{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "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": "93778",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0257-2024",
      "product_description": "Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217.  Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11",
      "product_quantity": "6,344 cartons",
      "reason_for_recall": "Superpotent drug: Assay results were slightly above specification at the time zero point.",
      "recall_initiation_date": "20231226",
      "center_classification_date": "20240119",
      "report_date": "20240131",
      "code_info": "Lot # 1014208, Exp Mar/31/2025"
    }
  ]
}