{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cary",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022156"
        ],
        "brand_name": [
          "CLEVIPREX"
        ],
        "generic_name": [
          "CLEVIPIDINE"
        ],
        "manufacturer_name": [
          "Chiesi USA, Inc."
        ],
        "product_ndc": [
          "10122-610",
          "10122-611"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CLEVIDIPINE"
        ],
        "rxcui": [
          "1790239",
          "1790242",
          "1790245",
          "1790246"
        ],
        "spl_id": [
          "e472cde4-d29e-44b2-b1ca-a6f4fcc01b1d"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "10122-611-01",
          "10122-611-10",
          "10122-610-01",
          "10122-610-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000069",
          "N0000175421",
          "M0006414"
        ],
        "pharm_class_moa": [
          "Calcium Channel Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Dihydropyridine Calcium Channel Blocker [EPC]"
        ],
        "pharm_class_cs": [
          "Dihydropyridines [CS]"
        ],
        "unii": [
          "19O2GP3B7Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99376",
      "recalling_firm": "Chiesi USA, Inc.",
      "address_1": "175 Regency Woods Pl Ste 600",
      "address_2": "",
      "postal_code": "27518-6007",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0689-2026",
      "product_description": "CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.",
      "product_quantity": "44280 vials",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260706",
      "center_classification_date": "20260714",
      "report_date": "20260722",
      "code_info": "Lot #: 1239521, 1237454, Exp. Date 10/2027",
      "more_code_info": ""
    }
  ]
}