{
  "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": "Terminated",
      "city": "Alpharetta",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205327"
        ],
        "brand_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "generic_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Trigen Laboratories, LLC"
        ],
        "product_ndc": [
          "13811-706",
          "13811-709",
          "13811-707",
          "13811-708",
          "13811-710"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1091155",
          "1091170",
          "1091185",
          "1091210",
          "1995461"
        ],
        "spl_id": [
          "0944cf70-d59a-483b-9698-e96ef955a65a"
        ],
        "spl_set_id": [
          "c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f"
        ],
        "package_ndc": [
          "13811-709-10",
          "13811-706-10",
          "13811-707-10",
          "13811-708-10",
          "13811-710-10",
          "13811-710-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0313811706109",
          "0313811708103"
        ],
        "unii": [
          "4B3SC438HI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94818",
      "recalling_firm": "Trigen Laboratories",
      "address_1": "1880 Mcfarland Pkwy",
      "address_2": "ste 110",
      "postal_code": "30005-1794",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0579-2024",
      "product_description": "Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10",
      "product_quantity": "10,448 100-count bottles",
      "reason_for_recall": "Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.",
      "recall_initiation_date": "20240617",
      "center_classification_date": "20240702",
      "termination_date": "20250923",
      "report_date": "20240710",
      "code_info": "Lot 230159M, Exp Date 2/28/2026"
    }
  ]
}