{
  "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": "Chantilly",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209313"
        ],
        "brand_name": [
          "METFORMIN ER 500 MG"
        ],
        "generic_name": [
          "METFORMIN ER 500 MG"
        ],
        "manufacturer_name": [
          "Quallent Pharmaceuticals Health LLC"
        ],
        "product_ndc": [
          "82009-117",
          "82009-118"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "860975",
          "860981"
        ],
        "spl_id": [
          "451e9a75-128c-6b1d-e063-6394a90aa5d8"
        ],
        "spl_set_id": [
          "ff196435-14f4-8b9d-e053-6294a90a4ee8"
        ],
        "package_ndc": [
          "82009-117-10",
          "82009-118-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0382009117102",
          "0382009118017"
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96082",
      "recalling_firm": "Granules Pharmaceuticals Inc.",
      "address_1": "3701 Concorde Pkwy",
      "address_2": "",
      "postal_code": "20151-1126",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Distributor in OH.",
      "recall_number": "D-0192-2025",
      "product_description": "Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10",
      "product_quantity": "6,804 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.",
      "recall_initiation_date": "20241230",
      "center_classification_date": "20250108",
      "termination_date": "20260115",
      "report_date": "20250115",
      "code_info": "Lot #: 4911311A, Exp. Date: 11/2025",
      "more_code_info": ""
    }
  ]
}