{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Madison",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022315"
        ],
        "brand_name": [
          "OZURDEX"
        ],
        "generic_name": [
          "DEXAMETHASONE"
        ],
        "manufacturer_name": [
          "Allergan, Inc."
        ],
        "product_ndc": [
          "0023-3348"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVITREAL"
        ],
        "substance_name": [
          "DEXAMETHASONE"
        ],
        "spl_id": [
          "007c310d-2cfe-4c54-a27e-693e0d7fa78a"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0023-3348-07",
          "0023-3348-08"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "7S5I7G3JQL"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81855",
      "recalling_firm": "Allergan, PLC.",
      "address_1": "5 Giralda Farms",
      "address_2": "",
      "postal_code": "07940-1027",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to various accounts throughout the United States including VA and Government Accounts",
      "recall_number": "D-0387-2019",
      "product_description": "OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07",
      "product_quantity": "133,716 Cartons",
      "reason_for_recall": "GMP Deviations: A silicone particulate was noted in Ozurdex.",
      "recall_initiation_date": "20181220",
      "center_classification_date": "20190118",
      "report_date": "20190116",
      "code_info": "E78689, exp. date 06/21/2019    E78726, exp. date 06/29/2019    E78729, exp. date 07/01/2019   E78894, exp. date 08/09/2019   E79157, exp. date 09/05/2019   E79233, exp. date 09/15/2019    E79366, exp. date 10/06/2019    E79891, exp. date 12/07/2019     E80122, exp. date 01/18/2020   E80216, exp. date 02/06/2020   E81080, exp. date 05/09/2020   E81083, exp. date 05/22/2020  E81273, exp. date 05/31/2020  E81344, exp. date 06/21/2020  E82526, exp. date 12/11/2020  E82638, exp. date 12/20/2020  E82738, exp. date 01/18/2021  E82741, exp. date 01/23/2021  E82847, exp. date 01/29/2021  E82852, exp. date 02/01/2021  E83029, exp. date 02/26/2021  E83364, exp. date 04/18/2021",
      "more_code_info": ""
    }
  ]
}