{
  "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": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA202867"
        ],
        "brand_name": [
          "MOXIFLOXACIN"
        ],
        "generic_name": [
          "MOXIFLOXACIN"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-422"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE"
        ],
        "rxcui": [
          "403818"
        ],
        "spl_id": [
          "40262fef-9713-4538-b96b-c44b257d6a25"
        ],
        "spl_set_id": [
          "ae77e219-8af9-4aa4-96d3-05c9726a1d3c"
        ],
        "package_ndc": [
          "68180-422-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180422013"
        ],
        "unii": [
          "B8956S8609"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80668",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "N/A",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States",
      "recall_number": "D-1050-2018",
      "product_description": "Moxifloxacin Ophthalmic Solution USP, 0.5%,  5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01",
      "product_quantity": "13,896 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.",
      "recall_initiation_date": "20180726",
      "center_classification_date": "20180808",
      "termination_date": "20191206",
      "report_date": "20180808",
      "code_info": "Lot #: H800393, Exp. 01/2020"
    }
  ]
}