{
  "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": "82037",
      "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 by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.",
      "recall_number": "D-0484-2019",
      "product_description": "Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01",
      "product_quantity": "43,860 3ml  bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.",
      "recall_initiation_date": "20190201",
      "center_classification_date": "20190208",
      "termination_date": "20200626",
      "report_date": "20190220",
      "code_info": "Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020"
    }
  ]
}