{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA210913"
        ],
        "brand_name": [
          "CEQUA"
        ],
        "generic_name": [
          "CYCLOSPORINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-506",
          "47335-507"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC",
          "TOPICAL"
        ],
        "substance_name": [
          "CYCLOSPORINE"
        ],
        "rxcui": [
          "2055021",
          "2055026"
        ],
        "spl_id": [
          "0c4be5cb-4e73-413f-847c-66babed20757"
        ],
        "spl_set_id": [
          "48c3d8a3-4289-4b52-9189-58b48596095c"
        ],
        "package_ndc": [
          "47335-506-96",
          "47335-507-97"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175457",
          "N0000175458",
          "N0000182141",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Calcineurin Inhibitor Immunosuppressant [EPC]"
        ],
        "pharm_class_moa": [
          "Calcineurin Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "83HN0GTJ6D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89917",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0770-2022",
      "product_description": "Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ  08512, NDC 47335-506-96",
      "product_quantity": "73,030 boxes",
      "reason_for_recall": "Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.",
      "recall_initiation_date": "20220401",
      "center_classification_date": "20220414",
      "termination_date": "20230721",
      "report_date": "20220413",
      "code_info": "Lot: 10014, 10016, Exp 08/2022",
      "more_code_info": ""
    }
  ]
}