{
  "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": "Alpharetta",
      "state": "GA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020356"
        ],
        "brand_name": [
          "NISOLDIPINE"
        ],
        "generic_name": [
          "NISOLDIPINE"
        ],
        "manufacturer_name": [
          "Prasco Laboratories"
        ],
        "product_ndc": [
          "66993-472",
          "66993-473",
          "66993-475"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NISOLDIPINE"
        ],
        "rxcui": [
          "763519",
          "763589",
          "790489"
        ],
        "spl_id": [
          "a999e1d0-199c-4631-8a51-8dc27e05f3ab"
        ],
        "spl_set_id": [
          "8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb"
        ],
        "package_ndc": [
          "66993-472-02",
          "66993-473-02",
          "66993-475-02",
          "59630-501-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175421",
          "M0006414",
          "N0000000069",
          "N0000178477"
        ],
        "pharm_class_epc": [
          "Dihydropyridine Calcium Channel Blocker [EPC]"
        ],
        "pharm_class_cs": [
          "Dihydropyridines [CS]"
        ],
        "pharm_class_moa": [
          "Calcium Channel Antagonists [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Blood Pressure [PE]"
        ],
        "unii": [
          "4I8HAB65SZ"
        ],
        "upc": [
          "359630501105"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71828",
      "recalling_firm": "Shionogi Inc.",
      "address_1": "5770 Shiloh Rd",
      "address_2": "N/A",
      "postal_code": "30005-8408",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1284-2015",
      "product_description": "Nisoldipine Extended Release Tablets, 17 mg, packaged as a)  Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH  45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.",
      "product_quantity": "a) 483 bottles; b) 5,631 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20150724",
      "center_classification_date": "20150804",
      "termination_date": "20160414",
      "report_date": "20150812",
      "code_info": "Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16"
    }
  ]
}