{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022276"
        ],
        "brand_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9633",
          "0143-9689",
          "0143-9634"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "858599",
          "858603",
          "858607"
        ],
        "spl_id": [
          "299a0b28-ebf0-4753-983d-b9a16158d83c"
        ],
        "spl_set_id": [
          "18fb1c2b-0c1e-436c-a5b6-d4840b5da228"
        ],
        "package_ndc": [
          "0143-9689-01",
          "0143-9689-10",
          "0143-9633-01",
          "0143-9633-10",
          "0143-9634-01",
          "0143-9634-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "K5BC5011K3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65287",
      "recalling_firm": "West-ward Pharmaceutical Corp.",
      "address_1": "465 Industrial Way W",
      "address_2": "N/A",
      "postal_code": "07724-2209",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-691-2013",
      "product_description": "Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10",
      "product_quantity": "Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials",
      "reason_for_recall": "Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)",
      "recall_initiation_date": "20130513",
      "center_classification_date": "20130711",
      "termination_date": "20150317",
      "report_date": "20130717",
      "code_info": "Lot PLNJ1201 APRIL 2014  Lot PLNJ1202 MAY 2014"
    }
  ]
}