{
  "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": "2026-06-03",
    "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"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4S9CL2DY2H",
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98536",
      "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": "U.S. Nationwide",
      "recall_number": "D-0407-2026",
      "product_description": "Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.",
      "product_quantity": "107,136 vials",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260305",
      "center_classification_date": "20260327",
      "report_date": "20260325",
      "code_info": "Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027",
      "more_code_info": ""
    }
  ]
}