{
  "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": "71594",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "425 Privet Rd",
      "address_2": "N/A",
      "postal_code": "19044-1220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1283-2015",
      "product_description": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg   (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02",
      "product_quantity": "19,504 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: out of specification for unknown impurity",
      "recall_initiation_date": "20150624",
      "center_classification_date": "20150803",
      "termination_date": "20160817",
      "report_date": "20150812",
      "code_info": "Lot #: 34015862A, Exp. Date 6/2016  Lot #: 34016376A, Exp. Date 7/2016"
    }
  ]
}