{
  "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": "Elizabeth",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077302"
        ],
        "brand_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE"
        ],
        "generic_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0228-3059",
          "0228-3062",
          "0228-3063",
          "0228-3060",
          "0228-3064",
          "0228-3061"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMPHETAMINE ASPARTATE MONOHYDRATE",
          "AMPHETAMINE SULFATE",
          "DEXTROAMPHETAMINE SACCHARATE",
          "DEXTROAMPHETAMINE SULFATE"
        ],
        "rxcui": [
          "861221",
          "861223",
          "861225",
          "861227",
          "861232",
          "861237"
        ],
        "spl_id": [
          "75c254af-0db3-4c40-83ad-f308be628dde"
        ],
        "spl_set_id": [
          "c5c2d060-452c-4f76-ad93-2e41fd8f06c2"
        ],
        "package_ndc": [
          "0228-3062-11",
          "0228-3059-11",
          "0228-3063-11",
          "0228-3060-11",
          "0228-3064-11",
          "0228-3061-11"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0302283059110",
          "0302283064114",
          "0302283063117"
        ],
        "unii": [
          "G83415V073",
          "6DPV8NK46S",
          "O1ZPV620O4",
          "JJ768O327N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64506",
      "recalling_firm": "Actavis Elizabeth LLC",
      "address_1": "200 Elmora Ave",
      "address_2": "N/A",
      "postal_code": "07207",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-190-2013",
      "product_description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.",
      "product_quantity": "9,264 Bottles",
      "reason_for_recall": "Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications.  All other test specifications were met.",
      "recall_initiation_date": "20130213",
      "center_classification_date": "20130307",
      "termination_date": "20140306",
      "report_date": "20130313",
      "code_info": "Lot #: 50077231"
    }
  ]
}