{
  "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": "Terminated",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020439"
        ],
        "brand_name": [
          "BETIMOL"
        ],
        "generic_name": [
          "TIMOLOL"
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        "manufacturer_name": [
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        ],
        "product_ndc": [
          "82584-001",
          "82584-002"
        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
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        ],
        "rxcui": [
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          "1992305",
          "2702393",
          "2702398"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "82584-001-05",
          "82584-002-05",
          "82584-002-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0382584002053"
        ],
        "unii": [
          "817W3C6175"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94146",
      "recalling_firm": "Thea Pharma, Inc.",
      "address_1": "303 Wyman St",
      "address_2": "N/A",
      "postal_code": "02451-1208",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide within the United States",
      "recall_number": "D-0374-2024",
      "product_description": "Betimol (timolol ophthalmic solution) 0.5%,  15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15",
      "product_quantity": "5,476 bottles",
      "reason_for_recall": "Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.",
      "recall_initiation_date": "20240305",
      "center_classification_date": "20240311",
      "termination_date": "20250630",
      "report_date": "20240320",
      "code_info": "Lot #: 435019, Exp. Date 11/2024"
    }
  ]
}