{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Toronto",
      "state": "",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020936"
        ],
        "brand_name": [
          "PAROXETINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "PAROXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Apotex Corp"
        ],
        "product_ndc": [
          "60505-1316",
          "60505-1317",
          "60505-1318",
          "60505-3673",
          "60505-3674",
          "60505-3675"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAROXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1738803",
          "1738805",
          "1738807"
        ],
        "spl_id": [
          "f641c7b3-f7d2-9446-e589-074ac368853a"
        ],
        "spl_set_id": [
          "087ff0d3-1761-47ea-a8c1-7c4cb679af97"
        ],
        "package_ndc": [
          "60505-1316-3",
          "60505-1317-3",
          "60505-1318-3",
          "60505-3673-3",
          "60505-3674-3",
          "60505-3675-3"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0360505367436",
          "0360505367535",
          "0360505367337"
        ],
        "unii": [
          "X2ELS050D8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68967",
      "recalling_firm": "Apotex Inc.",
      "address_1": "150 Signet Drive",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1574-2014",
      "product_description": "Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3",
      "product_quantity": "",
      "reason_for_recall": "Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",
      "recall_initiation_date": "20140324",
      "center_classification_date": "20140903",
      "termination_date": "20140923",
      "report_date": "20140910",
      "code_info": "Lot # 2A001, Exp. 01/15  Lot # 2A002, Exp. 01/15  Lot # 2C003, Exp. 03/15  Lot # 2F005, Exp. 06/15  Lot # 2G006, Exp. 07/15",
      "more_code_info": ""
    }
  ]
}