{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Tampa",
      "state": "FL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040064"
        ],
        "brand_name": [
          "TROPICAMIDE"
        ],
        "generic_name": [
          "TROPICAMIDE"
        ],
        "manufacturer_name": [
          "Bausch & Lomb Incorporated"
        ],
        "product_ndc": [
          "24208-585",
          "24208-590"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "TROPICAMIDE"
        ],
        "rxcui": [
          "313521",
          "314238"
        ],
        "spl_id": [
          "f7ca9591-4d7b-4c5e-b54e-e08fd8cf6755"
        ],
        "spl_set_id": [
          "892b78c8-36bc-47d3-850e-502899b48fb9"
        ],
        "package_ndc": [
          "24208-590-64",
          "24208-585-59",
          "24208-585-64"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175574",
          "N0000175370"
        ],
        "pharm_class_epc": [
          "Anticholinergic [EPC]"
        ],
        "pharm_class_moa": [
          "Cholinergic Antagonists [MoA]"
        ],
        "unii": [
          "N0A3Z5XTC6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73032",
      "recalling_firm": "Bausch & Lomb, Inc.",
      "address_1": "8500 Hidden River Pkwy",
      "address_2": "N/A",
      "postal_code": "33637-1014",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide including Puerto Rico.",
      "recall_number": "D-0647-2016",
      "product_description": "Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.",
      "product_quantity": "a) 416,441 Bottles b) 674,177 Bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.",
      "recall_initiation_date": "20160118",
      "center_classification_date": "20160128",
      "termination_date": "20200106",
      "report_date": "20160203",
      "code_info": "a) Lot #: 232601, Expiry: 01/2016; Lot #: 233471, Expiry: 02/2016; Lot #: 234901, Expiry: 03/2016; Lot #: 238861, Expiry: 04/2016; Lot #: 239781, Expiry: 04/2016; Lot #: 243351, Expiry: 08/2016; Lot #: 244931, Expiry: 09/2016. b) Lot #: 198821, Expiry: 01/2016; Lot #: 198901, Expiry: 01/2016; Lot #: 199961, Expiry: 02/2016; Lot #: 220111, Expiry: 02/2016; Lot #: 222281, Expiry: 04/2016; Lot #: 222291, Expiry: 04/2016; Lot #: 224841, Expiry: 06/2016; Lot #: 228281, Expiry: 07/2016; Lot #: 228291, Expiry: 07/2016; Lot #: 231531, 10/2016; Lot #: 232671, Expiry: 11/2016; Lot #: 232681, Expiry: 11/2016; Lot #: 238931, 01/2017; Lot #: 238941, Expiry: 01/2017; Lot #: 240331, Expiry: 02/2017; Lot #: 242341, Expiry: 04/2017; Lot #: 242351, Expiry: 04/2017; Lot #: 243391, Expiry: 05/2017; Lot #: 246171, Expiry: 06/2017; Lot #: 246341, Expiry: 07/2017."
    }
  ]
}