{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075356"
        ],
        "brand_name": [
          "PAROXETINE"
        ],
        "generic_name": [
          "PAROXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-0083",
          "60505-0097",
          "60505-0084",
          "60505-0101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAROXETINE HYDROCHLORIDE ANHYDROUS"
        ],
        "rxcui": [
          "1738483",
          "1738495",
          "1738503",
          "1738511"
        ],
        "spl_id": [
          "9cde2ef4-fd50-ed21-0628-cb6cd8a6153f"
        ],
        "spl_set_id": [
          "08320ea3-8f93-6f04-5d1c-f69af3eb5a81"
        ],
        "package_ndc": [
          "60505-0097-1",
          "60505-0097-9",
          "60505-0097-2",
          "60505-0097-4",
          "60505-0097-7",
          "60505-0097-5",
          "60505-0083-1",
          "60505-0083-9",
          "60505-0083-2",
          "60505-0083-4",
          "60505-0083-0",
          "60505-0083-5",
          "60505-0084-1",
          "60505-0084-9",
          "60505-0084-2",
          "60505-0084-4",
          "60505-0084-5",
          "60505-0101-1",
          "60505-0101-9",
          "60505-0101-2",
          "60505-0101-4",
          "60505-0101-5",
          "60505-0101-7"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0360505010110",
          "0360505008414",
          "0360505009718",
          "0360505008315"
        ],
        "unii": [
          "3I3T11UD2S"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93353",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy Ste 400",
      "address_2": "",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0121-2024",
      "product_description": "Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.",
      "product_quantity": "25,776",
      "reason_for_recall": "Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine",
      "recall_initiation_date": "20231101",
      "center_classification_date": "20231127",
      "report_date": "20231206",
      "code_info": "Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024",
      "more_code_info": ""
    }
  ]
}