{
  "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": "69483",
      "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": "U.S. Nationwide including Puerto Rico.",
      "recall_number": "D-0050-2015",
      "product_description": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA  18960, NDC: 0555-0972-02.   0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.",
      "product_quantity": "19,545 Bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.",
      "recall_initiation_date": "20141008",
      "center_classification_date": "20141027",
      "termination_date": "20150921",
      "report_date": "20141105",
      "code_info": "Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.",
      "more_code_info": ""
    }
  ]
}