{
  "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": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211121"
        ],
        "brand_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-183"
        ],
        "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": [
          "55150-183-01",
          "55150-183-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150183012"
        ],
        "unii": [
          "K5BC5011K3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94073",
      "recalling_firm": "Eugia US LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0390-2024",
      "product_description": "Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only,  Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10",
      "product_quantity": "335,940 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification for organic impurities",
      "recall_initiation_date": "20240220",
      "center_classification_date": "20240319",
      "report_date": "20240327",
      "code_info": "Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016,  3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24",
      "more_code_info": ""
    }
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}