{
  "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": [
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        "substance_name": [
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        "rxcui": [
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          "1992303"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "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"
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        "unii": [
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94990",
      "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 in the US",
      "recall_number": "D-0632-2024",
      "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": "362,544 bottles",
      "reason_for_recall": "Defective container; yellow colored spike from cap lodged in the nozzle",
      "recall_initiation_date": "20240718",
      "center_classification_date": "20240813",
      "report_date": "20240821",
      "code_info": "Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25",
      "more_code_info": ""
    }
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}