{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203901"
        ],
        "brand_name": [
          "DEXTROAMPHETAMINE SULFATE"
        ],
        "generic_name": [
          "DEXTROAMPHETAMINE SULFATE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "45963-303",
          "45963-304",
          "45963-305"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROAMPHETAMINE SULFATE"
        ],
        "rxcui": [
          "884520",
          "884532",
          "884535"
        ],
        "spl_id": [
          "352be1be-4f30-4afe-9ec2-6108c1b9a9d7"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "45963-303-09",
          "45963-304-09",
          "45963-305-09"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "JJ768O327N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74713",
      "recalling_firm": "Actavis Inc",
      "address_1": "400 Interpace Pkwy",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1448-2016",
      "product_description": "Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA   NDC 45963-304-09",
      "product_quantity": "8,062 units",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20160711",
      "center_classification_date": "20160726",
      "termination_date": "20170216",
      "report_date": "20160803",
      "code_info": "Lot #: 3803J141, Exp. 7/2016"
    }
  ]
}