{
  "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": "Completed",
      "city": "Seymour",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215565"
        ],
        "brand_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "generic_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "manufacturer_name": [
          "Lannett Company, Inc."
        ],
        "product_ndc": [
          "0527-0760",
          "0527-0761",
          "0527-0762",
          "0527-0763",
          "0527-0764",
          "0527-0765",
          "0527-0766"
        ],
        "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": [
          "e0804f43-4685-4017-b839-3212d1167362"
        ],
        "spl_set_id": [
          "f92497b5-baea-4760-b615-45a0b6184402"
        ],
        "package_ndc": [
          "0527-0760-37",
          "0527-0761-37",
          "0527-0762-37",
          "0527-0763-37",
          "0527-0764-37",
          "0527-0765-37",
          "0527-0766-37"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "JJ768O327N",
          "6DPV8NK46S",
          "G83415V073",
          "O1ZPV620O4"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97461",
      "recalling_firm": "Lannett Company Inc.",
      "address_1": "1101 C Ave W",
      "address_2": "N/A",
      "postal_code": "47274-3342",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "OH",
      "recall_number": "D-0642-2025",
      "product_description": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.",
      "product_quantity": "4,848 bottles",
      "reason_for_recall": "Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.",
      "recall_initiation_date": "20250819",
      "center_classification_date": "20250911",
      "report_date": "20250917",
      "code_info": "Lot#: 25283185A. Expiry: 02/28/2027"
    }
  ]
}