{
  "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": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091442"
        ],
        "brand_name": [
          "BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION"
        ],
        "generic_name": [
          "BRIMONIDINE TARTRATE AND TIMOLOL MALEATE"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-0589"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BRIMONIDINE TARTRATE",
          "TIMOLOL MALEATE"
        ],
        "rxcui": [
          "861635"
        ],
        "spl_id": [
          "afc08ce8-3d89-644d-abdc-61a96ad5d107"
        ],
        "spl_set_id": [
          "268c3f6b-8798-7987-3b8c-7b7f560af5d7"
        ],
        "package_ndc": [
          "60505-0589-1",
          "60505-0589-2",
          "60505-0589-3",
          "0036050505",
          "6050505892"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4S9CL2DY2H",
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97561",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy Ste 400",
      "address_2": "N/A",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0676-2025",
      "product_description": "Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).",
      "product_quantity": "151,034 bottles",
      "reason_for_recall": "Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns",
      "recall_initiation_date": "20250905",
      "center_classification_date": "20250930",
      "report_date": "20251008",
      "code_info": "a) lot # VE0614 exp. date 12/2025 UPC:(01)00360505058914 (5 mL)  b) lot # VE0616 exp. date 12/2025 UPC:(01)0(03)60505058921 (10 mL)"
    }
  ]
}