{
  "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": "Jersey City",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022117"
        ],
        "brand_name": [
          "SAPHRIS"
        ],
        "generic_name": [
          "ASENAPINE MALEATE"
        ],
        "manufacturer_name": [
          "Allergan, Inc."
        ],
        "product_ndc": [
          "0456-2402",
          "0456-2405",
          "0456-2410"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBLINGUAL"
        ],
        "substance_name": [
          "ASENAPINE MALEATE"
        ],
        "rxcui": [
          "859975",
          "859979",
          "859981",
          "859983",
          "1606337",
          "1606490"
        ],
        "spl_id": [
          "9827c4dd-ffac-4022-a021-d1b15a364ecd"
        ],
        "spl_set_id": [
          "5429f134-839f-4ffc-9944-55f51238def8"
        ],
        "package_ndc": [
          "0456-2402-10",
          "0456-2402-06",
          "0456-2402-60",
          "0456-2402-11",
          "0456-2402-63",
          "0456-2405-10",
          "0456-2405-06",
          "0456-2405-60",
          "0456-2405-11",
          "0456-2405-63",
          "0456-2410-10",
          "0456-2410-06",
          "0456-2410-60",
          "0456-2410-11",
          "0456-2410-63"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "CU9463U2E2"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77315",
      "recalling_firm": "Forest Laboratories, LLC",
      "address_1": "Harborside Financial Center",
      "address_2": "Plaza V- Suite 1900",
      "postal_code": "07311",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0880-2017",
      "product_description": "Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06",
      "product_quantity": "40,621 blister packs",
      "reason_for_recall": "Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets",
      "recall_initiation_date": "20170518",
      "center_classification_date": "20170531",
      "termination_date": "20181115",
      "report_date": "20170607",
      "code_info": "Lots W00733 and W00946, exp Apr 2019",
      "more_code_info": ""
    }
  ]
}