{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "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"
        ],
        "spl_id": [
          "fba70df6-5d37-4a12-bce3-e6fb1b0c72b2"
        ],
        "spl_set_id": [
          "30fb3a4d-fa75-42fd-b4b6-2a21f202027f"
        ],
        "package_ndc": [
          "72572-470-01",
          "72572-470-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "K5BC5011K3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96695",
      "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": "Nationwide in the USA",
      "recall_number": "D-0398-2025",
      "product_description": "niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.",
      "product_quantity": "29,777 (cartons of 10 x 10mL vials)",
      "reason_for_recall": "Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.",
      "recall_initiation_date": "20250418",
      "center_classification_date": "20250501",
      "report_date": "20250507",
      "code_info": "Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026",
      "more_code_info": ""
    }
  ]
}