{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waco",
      "state": "TX",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021398"
        ],
        "brand_name": [
          "COMBIGAN"
        ],
        "generic_name": [
          "BRIMONIDINE TARTRATE, TIMOLOL MALEATE"
        ],
        "manufacturer_name": [
          "Allergan, Inc."
        ],
        "product_ndc": [
          "0023-9211"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BRIMONIDINE TARTRATE",
          "TIMOLOL MALEATE"
        ],
        "rxcui": [
          "861635",
          "861637"
        ],
        "spl_id": [
          "b31201db-b90e-4f4c-980f-0a206e63e36c"
        ],
        "spl_set_id": [
          "feaf1480-a4b8-4486-992a-96be3a596243"
        ],
        "package_ndc": [
          "0023-9211-03",
          "0023-9211-05",
          "0023-9211-10",
          "0023-9211-15"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4S9CL2DY2H",
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78325",
      "recalling_firm": "Allergan Sales, LLC",
      "address_1": "8301 Mars Dr",
      "address_2": "N/A",
      "postal_code": "76712-6578",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and  Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.",
      "recall_number": "D-0077-2018",
      "product_description": "Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..",
      "product_quantity": "715,041 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications.",
      "recall_initiation_date": "20171019",
      "center_classification_date": "20171113",
      "termination_date": "20191030",
      "report_date": "20171122",
      "code_info": "Lot #: a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-2019;  c) 95223 Exp. MAR-2019; d) 95220 Exp. MAR-2019"
    }
  ]
}