{
  "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": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077584"
        ],
        "brand_name": [
          "PAROXETINE"
        ],
        "generic_name": [
          "PAROXETINE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-001",
          "68382-097",
          "68382-098",
          "68382-099"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAROXETINE HYDROCHLORIDE HEMIHYDRATE"
        ],
        "rxcui": [
          "1738483",
          "1738495",
          "1738503",
          "1738511"
        ],
        "spl_id": [
          "c88d98d1-e370-4ad8-869a-603875f276cc"
        ],
        "spl_set_id": [
          "a6bb4f0a-1555-4550-a7a4-99609674b1e7"
        ],
        "package_ndc": [
          "68382-097-16",
          "68382-097-01",
          "68382-097-05",
          "68382-097-10",
          "68382-097-06",
          "68382-098-06",
          "68382-098-16",
          "68382-098-01",
          "68382-098-05",
          "68382-098-10",
          "68382-099-06",
          "68382-099-16",
          "68382-099-01",
          "68382-099-05",
          "68382-099-10",
          "68382-001-06",
          "68382-001-16",
          "68382-001-01",
          "68382-001-05",
          "68382-001-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382098108",
          "0368382099105"
        ],
        "unii": [
          "X2ELS050D8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78612",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0101-2018",
      "product_description": "Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06),   b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534",
      "product_quantity": "19812 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets",
      "recall_initiation_date": "20171120",
      "center_classification_date": "20171130",
      "termination_date": "20200901",
      "report_date": "20171206",
      "code_info": "a) Z701308, b) Z701309, c) Z701310 exp April 2019"
    }
  ]
}