{
  "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": "Largo",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040088"
        ],
        "brand_name": [
          "METHADONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "METHADONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "VistaPharm, LLC"
        ],
        "product_ndc": [
          "66689-694",
          "66689-695"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHADONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991147"
        ],
        "spl_id": [
          "a139d04a-25e0-499f-8bfb-43328f560410"
        ],
        "spl_set_id": [
          "d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb"
        ],
        "package_ndc": [
          "66689-694-30",
          "66689-694-79",
          "66689-694-88",
          "66689-695-79",
          "66689-695-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "229809935B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75650",
      "recalling_firm": "VistaPharm, Inc.",
      "address_1": "7265 Ulmerton Rd",
      "address_2": "N/A",
      "postal_code": "33771-4809",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0465-2017",
      "product_description": "Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79),  Rx only, Manufactured by VistaPharm, Largo, FL 33771.",
      "product_quantity": "127,193 bottles",
      "reason_for_recall": "CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.",
      "recall_initiation_date": "20170118",
      "center_classification_date": "20170202",
      "termination_date": "20210826",
      "report_date": "20170208",
      "code_info": "a). Lot No. 416600 (Exp. 09/17)  b). Lot No.449100 , 447500 (Exp. 04/18), 421800 (Exp. 10/17), 418600 (Exp. 09/17), 408700 (Exp. 06/17), 411900 (Exp. 07/17), 413800 (Exp. 08/17), 416500 (Exp. 09/17), 408500 (Exp. 06/17), 389800 (Exp. 01/17), 429900 (Exp. 12/17), 406300, 406100 (Exp. 05/17), 429700 (Exp. 12/17), 427300, 427100, 425900 (11/17)",
      "more_code_info": ""
    }
  ]
}