{
  "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": "Horsham",
      "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"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67412",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "425 Privet Rd",
      "address_2": "",
      "postal_code": "19044-1220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1094-2014",
      "product_description": "Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only,  Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.",
      "product_quantity": "9796 tablets",
      "reason_for_recall": "CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.",
      "recall_initiation_date": "20140124",
      "center_classification_date": "20140228",
      "termination_date": "20141008",
      "report_date": "20140312",
      "code_info": "Lot # 34017575A, Exp. 10/16.",
      "more_code_info": ""
    }
  ]
}