{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA019268"
        ],
        "brand_name": [
          "CYTOTEC"
        ],
        "generic_name": [
          "MISOPROSTOL"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0025-1451",
          "0025-1461"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MISOPROSTOL"
        ],
        "rxcui": [
          "104098",
          "209177",
          "311727",
          "317128"
        ],
        "spl_id": [
          "253d5240-18d7-4f06-8314-a5632648cd47"
        ],
        "spl_set_id": [
          "4ab12da7-5731-4e06-bf1c-bc3f2e711f12"
        ],
        "package_ndc": [
          "0025-1451-34",
          "0025-1451-60",
          "0025-1461-34",
          "0025-1461-60",
          "0025-1461-31"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300251461606"
        ],
        "nui": [
          "N0000175785",
          "M0017811"
        ],
        "pharm_class_epc": [
          "Prostaglandin E1 Analog [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins E, Synthetic [CS]"
        ],
        "unii": [
          "0E43V0BB57"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75321",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0424-2017",
      "product_description": "Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34",
      "product_quantity": "1,706 cartons",
      "reason_for_recall": "Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months",
      "recall_initiation_date": "20160909",
      "center_classification_date": "20170106",
      "termination_date": "20170818",
      "report_date": "20170118",
      "code_info": "1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018",
      "more_code_info": ""
    }
  ]
}