{
  "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": "Cranford",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077060"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Viona Pharmaceuticals Inc"
        ],
        "product_ndc": [
          "72578-035",
          "72578-036"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "860975",
          "860981"
        ],
        "spl_id": [
          "a00c6d0b-37fd-467e-a343-64b090412459"
        ],
        "spl_set_id": [
          "85027e6c-d35b-49eb-a234-dd71aa77aee0"
        ],
        "package_ndc": [
          "72578-035-01",
          "72578-035-05",
          "72578-036-01",
          "72578-036-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89305",
      "recalling_firm": "VIONA PHARMACEUTICALS INC",
      "address_1": "20 Commerce Dr Ste 340",
      "address_2": "",
      "postal_code": "07016-3617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 17 wholesalers who further distributed the product to 85 locations.",
      "recall_number": "D-0392-2022",
      "product_description": "Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles  NDC# 72578-036-01",
      "product_quantity": "23,8416/100 count bottles",
      "reason_for_recall": "CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.",
      "recall_initiation_date": "20211227",
      "center_classification_date": "20220121",
      "termination_date": "20230920",
      "report_date": "20220202",
      "code_info": "M008130 06/2022,  M008131 06/2022,  M008132 06/2022,  M008133 06/2022,  M010080 07/2022,  M010081 07/2022,  M011029 08/2022,  M011030 08/2022,  M011031 08/2022,  M011032 08/2022,  M011304 08/2022,  M013394 09/2022,  M013395 09/2022,  M013396 09/2022,  M013966 09/2022,  M013967 09/2022,  M100831 12/2022,  M100832 12/2022,  M100833 01/2023,  M100834 01/2023,  M101267 01/2023,  M102718 01/2023,  M102719 01/2023",
      "more_code_info": ""
    }
  ]
}