{
  "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,
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  "results": [
    {
      "status": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077584"
        ],
        "brand_name": [
          "PAROXETINE"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
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          "68382-097",
          "68382-098",
          "68382-099"
        ],
        "product_type": [
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        ],
        "route": [
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        ],
        "substance_name": [
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          "68382-001-05",
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        "is_original_packager": [
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        "upc": [
          "0368382098108",
          "0368382099105",
          "368382099068"
        ],
        "unii": [
          "X2ELS050D8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77963",
      "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 within United States",
      "recall_number": "D-1137-2017",
      "product_description": "Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8",
      "product_quantity": "44800 bottles",
      "reason_for_recall": "Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets",
      "recall_initiation_date": "20170818",
      "center_classification_date": "20170911",
      "termination_date": "20200106",
      "report_date": "20170920",
      "code_info": "Lot #: Z701133, Exp 03/19"
    }
  ]
}