{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Aurangabad, Maharashtra State",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077259"
        ],
        "brand_name": [
          "TIMOLOL MALEATE"
        ],
        "generic_name": [
          "TIMOLOL MALEATE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-513",
          "64980-514"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "TIMOLOL MALEATE"
        ],
        "rxcui": [
          "1923428",
          "1992303"
        ],
        "spl_id": [
          "7ef88352-6fe4-48a4-b72b-15419d3ed051"
        ],
        "spl_set_id": [
          "2ed21930-1e05-46de-8acd-cb6f4798a7fa"
        ],
        "package_ndc": [
          "64980-513-05",
          "64980-513-01",
          "64980-513-15",
          "64980-514-05",
          "64980-514-01",
          "64980-514-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364980513050",
          "0364980514057"
        ],
        "unii": [
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95140",
      "recalling_firm": "FDC Limited",
      "address_1": "B-8 MIDC Industrial Area",
      "address_2": "Waluj District",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide U.S.A.",
      "recall_number": "D-0642-2024",
      "product_description": "Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey",
      "product_quantity": "176,784 bottles",
      "reason_for_recall": "Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.",
      "recall_initiation_date": "20240812",
      "center_classification_date": "20240822",
      "report_date": "20240828",
      "code_info": "Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.",
      "more_code_info": ""
    }
  ]
}