{
  "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": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA204134"
        ],
        "brand_name": [
          "PAROXETINE"
        ],
        "generic_name": [
          "PAROXETINE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-645",
          "68180-647",
          "68180-646"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAROXETINE HYDROCHLORIDE HEMIHYDRATE"
        ],
        "rxcui": [
          "1738803",
          "1738805",
          "1738807"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "68180-647-06",
          "68180-647-01",
          "68180-647-02",
          "68180-647-03",
          "68180-646-06",
          "68180-646-01",
          "68180-646-02",
          "68180-646-03",
          "68180-645-06",
          "68180-645-01",
          "68180-645-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "X2ELS050D8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77606",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0974-2017",
      "product_description": "Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06",
      "product_quantity": "12480 bottles",
      "reason_for_recall": "Failed Dissolution Specifications:  out of specification observed in dissolution testing at 3 month long term stability study.",
      "recall_initiation_date": "20170622",
      "center_classification_date": "20170712",
      "termination_date": "20190117",
      "report_date": "20170719",
      "code_info": "Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019",
      "more_code_info": ""
    }
  ]
}