{
  "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": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021016"
        ],
        "brand_name": [
          "RELPAX"
        ],
        "generic_name": [
          "ELETRIPTAN HYDROBROMIDE"
        ],
        "manufacturer_name": [
          "ROERIG"
        ],
        "product_ndc": [
          "0049-2330",
          "0049-2340"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ELETRIPTAN HYDROBROMIDE"
        ],
        "rxcui": [
          "359493",
          "359494",
          "404443",
          "404444"
        ],
        "spl_id": [
          "f6f124bc-c3e3-4ab8-b081-51068ec75eb8"
        ],
        "spl_set_id": [
          "85745375-fcb6-4edc-b6db-a77b4a5f3e8c"
        ],
        "package_ndc": [
          "0049-2330-79",
          "0049-2330-45",
          "0049-2340-79",
          "0049-2340-45",
          "0049-2340-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "M41W832TA3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82715",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1278-2019",
      "product_description": "Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.",
      "product_quantity": "100277 tablets",
      "reason_for_recall": "Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.",
      "recall_initiation_date": "20190429",
      "center_classification_date": "20190513",
      "termination_date": "20210426",
      "report_date": "20190522",
      "code_info": "Lot #s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021.",
      "more_code_info": ""
    }
  ]
}