{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New Albany",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090534"
        ],
        "brand_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Civica, Inc."
        ],
        "product_ndc": [
          "72572-470"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "858607"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "72572-470-01",
          "72572-470-10"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "K5BC5011K3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94621",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "6610 New Albany Rd E",
      "address_2": "",
      "postal_code": "43054-8730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "UT only",
      "recall_number": "D-0503-2024",
      "product_description": "niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054.  NDC 72572-470-10",
      "product_quantity": "4,136 cartons (10 vials in each carton)",
      "reason_for_recall": "Lack of Assurance of Sterility.",
      "recall_initiation_date": "20240514",
      "center_classification_date": "20240521",
      "termination_date": "20251223",
      "report_date": "20240529",
      "code_info": "Lot #: 23087N0C0, Exp. Date 11/2024",
      "more_code_info": ""
    }
  ]
}