{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "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": "99503",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsay Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0802-2026",
      "product_description": "niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.",
      "product_quantity": "43,460 vials",
      "reason_for_recall": "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde",
      "recall_initiation_date": "20260724",
      "center_classification_date": "20260826",
      "report_date": "20260826",
      "code_info": "Lot #: 25295N0C0, Exp. Date: 04/30/2027.",
      "more_code_info": ""
    }
  ]
}