{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baudette",
      "state": "MN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205401"
        ],
        "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": [
          "ANI Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "43975-277",
          "43975-278",
          "43975-279",
          "43975-280",
          "43975-282",
          "43975-281"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMPHETAMINE DL-ASPARTATE MONOHYDRATE",
          "AMPHETAMINE SULFATE",
          "DEXTROAMPHETAMINE SACCHARATE",
          "DEXTROAMPHETAMINE SULFATE"
        ],
        "rxcui": [
          "861221",
          "861223",
          "861225",
          "861227",
          "861232",
          "861237"
        ],
        "spl_id": [
          "f25f7b30-b0dc-4d5c-b7d9-ddcb766ff559"
        ],
        "spl_set_id": [
          "6438480f-1147-42b6-826d-4e1e1f8ff007"
        ],
        "package_ndc": [
          "43975-277-10",
          "43975-278-10",
          "43975-279-10",
          "43975-280-10",
          "43975-282-10",
          "43975-281-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343975282102",
          "0343975281105",
          "0343975278105",
          "0343975280108",
          "0343975277108",
          "0343975279102"
        ],
        "unii": [
          "G83415V073",
          "6DPV8NK46S",
          "O1ZPV620O4",
          "JJ768O327N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "86584",
      "recalling_firm": "ANI Pharmaceuticals, Inc.",
      "address_1": "455 Idc Rd Sw",
      "address_2": "N/A",
      "postal_code": "56623-2467",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0043-2021",
      "product_description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10",
      "product_quantity": "408 bottles",
      "reason_for_recall": "Labeling: Incorrect expiration date.  Product dated with 24-month expiration date instead of 18-months.",
      "recall_initiation_date": "20201009",
      "center_classification_date": "20201021",
      "termination_date": "20220119",
      "report_date": "20201028",
      "code_info": "Lot: 19S07 Exp. Sept. 2021"
    }
  ]
}