{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Chantilly",
      "state": "VA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA217027"
        ],
        "brand_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "generic_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "manufacturer_name": [
          "Granules Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "70010-029",
          "70010-030",
          "70010-031",
          "70010-032",
          "70010-033",
          "70010-034"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROAMPHETAMINE SACCHARATE",
          "AMPHETAMINE ASPARTATE MONOHYDRATE",
          "DEXTROAMPHETAMINE SULFATE",
          "AMPHETAMINE SULFATE"
        ],
        "rxcui": [
          "861221",
          "861223",
          "861225",
          "861227",
          "861232",
          "861237"
        ],
        "spl_id": [
          "51ac9d68-0275-7d80-e063-6294a90a5ccb"
        ],
        "spl_set_id": [
          "8c672e06-0778-4a7d-b398-5bcbf2a73f12"
        ],
        "package_ndc": [
          "70010-029-01",
          "70010-030-01",
          "70010-031-01",
          "70010-032-01",
          "70010-033-01",
          "70010-034-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370010029019",
          "0370010030015",
          "0370010032019",
          "0370010034013",
          "0370010031012",
          "0370010033016"
        ],
        "unii": [
          "JJ768O327N",
          "6DPV8NK46S",
          "G83415V073",
          "O1ZPV620O4"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97504",
      "recalling_firm": "Granules Pharmaceuticals Inc.",
      "address_1": "3701 Concorde Pkwy",
      "address_2": "N/A",
      "postal_code": "20151-1126",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0672-2025",
      "product_description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01",
      "product_quantity": "11,909 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:",
      "recall_initiation_date": "20250828",
      "center_classification_date": "20250924",
      "report_date": "20251001",
      "code_info": "Lot#: GPC250179A, Exp Date:  06-22-2027",
      "more_code_info": ""
    }
  ]
}