{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "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": [
          "DEXTROAMPHETAMINE SACCHARATE",
          "AMPHETAMINE ASPARTATE MONOHYDRATE",
          "DEXTROAMPHETAMINE SULFATE",
          "AMPHETAMINE 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": [
          "JJ768O327N",
          "6DPV8NK46S",
          "O1ZPV620O4",
          "G83415V073"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90803",
      "recalling_firm": "Teva Pharmaceuticals USA Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US.",
      "recall_number": "D-1539-2022",
      "product_description": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.",
      "product_quantity": "83,703 bottles",
      "reason_for_recall": "Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.",
      "recall_initiation_date": "20220829",
      "center_classification_date": "20220916",
      "termination_date": "20230814",
      "report_date": "20220921",
      "code_info": "Lot #: 100023340, Exp 10/2024",
      "more_code_info": ""
    }
  ]
}