{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Allegan",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078830"
        ],
        "brand_name": [
          "SCOPOLAMINE TRANSDERMAL SYSTEM"
        ],
        "generic_name": [
          "SCOPOLAMINE TRANSDERMAL SYSTEM"
        ],
        "manufacturer_name": [
          "Padagis Israel Pharmaceuticals Ltd"
        ],
        "product_ndc": [
          "45802-580"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "SCOPOLAMINE"
        ],
        "rxcui": [
          "226552"
        ],
        "spl_id": [
          "d334a21d-7546-477f-a66a-f95b2cf523ce"
        ],
        "spl_set_id": [
          "cb93bfad-3e37-4a27-92f6-f21703ae7bdf"
        ],
        "package_ndc": [
          "45802-580-84",
          "45802-580-46",
          "45802-580-62",
          "45802-580-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175574",
          "N0000175370"
        ],
        "pharm_class_epc": [
          "Anticholinergic [EPC]"
        ],
        "pharm_class_moa": [
          "Cholinergic Antagonists [MoA]"
        ],
        "unii": [
          "DL48G20X8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80041",
      "recalling_firm": "L. Perrigo Company",
      "address_1": "515 Eastern Ave",
      "address_2": "",
      "postal_code": "49010-9070",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.A.",
      "recall_number": "D-0816-2018",
      "product_description": "Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010",
      "product_quantity": "569,520 cartons",
      "reason_for_recall": "Defective delivery system",
      "recall_initiation_date": "20180511",
      "center_classification_date": "20180515",
      "termination_date": "20200928",
      "report_date": "20180523",
      "code_info": "Lot #: a) 46397, 46457 Exp 03/19; 46621, Exp 04/19; 46894, 46904, 46905, Exp 06/19; 47133, Exp 07/19; 47153, Exp 08/19; 47154, 47213, 47214, Exp 09/19; b) 46695, Exp 04/19; 46994, 47012, Exp 07/19; 47322 10/19; c) 46822, Exp 05/19 ; 47155, 47212, Exp 09/19",
      "more_code_info": ""
    }
  ]
}