{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077584"
        ],
        "brand_name": [
          "PAROXETINE"
        ],
        "generic_name": [
          "PAROXETINE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "68084-044",
          "68084-045",
          "68084-046",
          "68084-047"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAROXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1738483",
          "1738495",
          "1738503",
          "1738511"
        ],
        "spl_id": [
          "3f163cc0-999c-9fdd-e063-6394a90ac15e"
        ],
        "spl_set_id": [
          "b5a8f864-a53d-48d9-aca6-6b64017fb168"
        ],
        "package_ndc": [
          "68084-044-11",
          "68084-044-01",
          "68084-045-11",
          "68084-045-01",
          "68084-046-11",
          "68084-046-01",
          "68084-047-11",
          "68084-047-01"
        ],
        "original_packager_product_ndc": [
          "68382-097",
          "68382-098",
          "68382-099",
          "68382-001"
        ],
        "unii": [
          "X2ELS050D8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78490",
      "recalling_firm": "Amerisource Health Services",
      "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-0091-2018",
      "product_description": "Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01",
      "product_quantity": "74 cartons (cartons of 100 individual unit doses)",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules.",
      "recall_initiation_date": "20171024",
      "center_classification_date": "20171121",
      "termination_date": "20180619",
      "report_date": "20171129",
      "code_info": "Lot 172291"
    }
  ]
}