{
  "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,
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    }
  },
  "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": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "64980-513-05",
          "64980-513-01",
          "64980-513-15",
          "64980-514-05",
          "64980-514-01",
          "64980-514-15"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0364980513050",
          "0364980514057"
        ],
        "unii": [
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97219",
      "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": "U.S Nationwide.",
      "recall_number": "D-0543-2025",
      "product_description": "Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.",
      "product_quantity": "154,176 bottles",
      "reason_for_recall": "Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.",
      "recall_initiation_date": "20250705",
      "center_classification_date": "20250729",
      "report_date": "20250806",
      "code_info": "Lot#: 083L061, Exp.: 11/2025.",
      "more_code_info": ""
    }
  ]
}