{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205050"
        ],
        "brand_name": [
          "TRAVOPROST OPHTHALMIC SOLUTION, 0.004%"
        ],
        "generic_name": [
          "TRAVOPROST OPHTHALMIC SOLUTION, 0.004%"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-9651"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "TRAVOPROST"
        ],
        "rxcui": [
          "284008"
        ],
        "spl_id": [
          "d78c5705-68ac-4363-b9ae-5facc60e2b79"
        ],
        "spl_set_id": [
          "00dc284f-fd96-423b-bb8f-b90ee13439bf"
        ],
        "package_ndc": [
          "0378-9651-32",
          "0378-9651-50"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175454",
          "M0017805"
        ],
        "pharm_class_epc": [
          "Prostaglandin Analog [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins [CS]"
        ],
        "unii": [
          "WJ68R08KX9"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89906",
      "recalling_firm": "Mylan Pharmaceuticals Inc",
      "address_1": "3711 Collins Ferry Rd",
      "address_2": "",
      "postal_code": "26505-2362",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0748-2022",
      "product_description": "Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.",
      "product_quantity": "20,112 bottles",
      "reason_for_recall": "Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.",
      "recall_initiation_date": "20220401",
      "center_classification_date": "20220406",
      "termination_date": "20230227",
      "report_date": "20220413",
      "code_info": "Lot # TV11W101, Exp Mar 2023",
      "more_code_info": ""
    }
  ]
}