{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020936"
        ],
        "brand_name": [
          "PAXIL"
        ],
        "generic_name": [
          "PAROXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Apotex Corp"
        ],
        "product_ndc": [
          "60505-4377",
          "60505-4378",
          "60505-4379",
          "60505-3668",
          "60505-3669",
          "60505-3670"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAROXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1738803",
          "1738804",
          "1738805",
          "1738806",
          "1738807",
          "1738808"
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        "spl_id": [
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        "spl_set_id": [
          "483bd97f-c4d0-4e23-aaa8-6334f4471e0c"
        ],
        "package_ndc": [
          "60505-4377-3",
          "60505-4378-3",
          "60505-4379-3",
          "60505-3668-3",
          "60505-3669-3",
          "60505-3670-3"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0360505366835",
          "0360505437733",
          "0360505366934"
        ],
        "unii": [
          "X2ELS050D8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99673",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy Ste 400",
      "address_2": "N/A",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0804-2026",
      "product_description": "Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3",
      "product_quantity": "6,972 bottles",
      "reason_for_recall": "Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria",
      "recall_initiation_date": "20260813",
      "center_classification_date": "20260827",
      "report_date": "20260902",
      "code_info": "Lot # TY9494, Exp Date: 05/31/2027."
    }
  ]
}