{
  "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": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-0735"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "858607"
        ],
        "spl_id": [
          "92ab3adc-2097-490a-a0b3-fa3fac098a2a"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
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          "0517-0735-10"
        ],
        "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-0399-2025",
      "product_description": "niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]",
      "product_quantity": "7,249 (cartons of 10 x 10 mL 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 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;",
      "more_code_info": ""
    }
  ]
}