{
  "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": "North Wales",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040422"
        ],
        "brand_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "generic_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0555-0775",
          "0555-0971",
          "0555-0972",
          "0555-0776",
          "0555-0777",
          "0555-0973",
          "0555-0974"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMPHETAMINE ASPARTATE MONOHYDRATE",
          "AMPHETAMINE SULFATE",
          "DEXTROAMPHETAMINE SACCHARATE",
          "DEXTROAMPHETAMINE SULFATE"
        ],
        "rxcui": [
          "541363",
          "541878",
          "541892",
          "577957",
          "577961",
          "687043",
          "1009145"
        ],
        "spl_id": [
          "88468f3d-7d03-4cee-aabf-3abc8c9b5e38"
        ],
        "spl_set_id": [
          "cffbbb15-d776-41ae-a8a6-687f2c07bfa4"
        ],
        "package_ndc": [
          "0555-0971-02",
          "0555-0775-02",
          "0555-0972-02",
          "0555-0776-02",
          "0555-0777-02",
          "0555-0973-02",
          "0555-0974-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "G83415V073",
          "6DPV8NK46S",
          "O1ZPV620O4",
          "JJ768O327N"
        ],
        "upc": [
          "305550972020"
        ]
      },
      "product_type": "Drugs",
      "event_id": "72988",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "1090 Horsham Rd",
      "address_2": "N/A",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0566-2016",
      "product_description": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.",
      "product_quantity": "9,717 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.",
      "recall_initiation_date": "20151112",
      "center_classification_date": "20160111",
      "termination_date": "20161101",
      "report_date": "20160120",
      "code_info": "Lot #: 34015516A, Exp 05/16"
    }
  ]
}