{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Newtown",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040886"
        ],
        "brand_name": [
          "PHENTERMINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "PHENTERMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "KVK-Tech, Inc."
        ],
        "product_ndc": [
          "10702-026",
          "10702-027",
          "10702-028"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PHENTERMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "900038",
          "968766"
        ],
        "spl_id": [
          "1662a72d-c285-b644-e063-6294a90a7333"
        ],
        "spl_set_id": [
          "b963f7bb-fa65-4e28-81c9-282fbe70a6a6"
        ],
        "package_ndc": [
          "10702-026-03",
          "10702-026-01",
          "10702-026-10",
          "10702-027-03",
          "10702-027-01",
          "10702-027-10",
          "10702-028-03",
          "10702-028-01",
          "10702-028-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310702027107",
          "0310702028104",
          "0310702026100"
        ],
        "unii": [
          "0K2I505OTV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77878",
      "recalling_firm": "KVK-Tech, Inc.",
      "address_1": "110 Terry Dr",
      "address_2": "N/A",
      "postal_code": "18940-3427",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the United States",
      "recall_number": "D-1083-2017",
      "product_description": "Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940",
      "product_quantity": "35,267 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.",
      "recall_initiation_date": "20170803",
      "center_classification_date": "20170811",
      "termination_date": "20181204",
      "report_date": "20170823",
      "code_info": "Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017;   b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017"
    }
  ]
}