{
  "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": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021591"
        ],
        "brand_name": [
          "RIOMET"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "10631-206",
          "10631-238"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "861025",
          "861027"
        ],
        "spl_id": [
          "8ed86d67-8a49-4334-82c4-1dbf6a489d3b"
        ],
        "spl_set_id": [
          "05d4df4b-dfe8-4828-b423-a3d4f2c4114a"
        ],
        "package_ndc": [
          "10631-238-01",
          "10631-238-02",
          "10631-206-01",
          "10631-206-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79979",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide in the USA",
      "recall_number": "D-0818-2018",
      "product_description": "Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02",
      "product_quantity": "19,758 473 mL bottles",
      "reason_for_recall": "Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.",
      "recall_initiation_date": "20180426",
      "center_classification_date": "20180516",
      "termination_date": "20190228",
      "report_date": "20180523",
      "code_info": "Lot Numbers: E170210A, EXP 06/09/2019; F170214A, 07/05/2019; F170223A, EXP 07/06/2019; F170224A EXP 07/10/2019; F170231A , EXP 07/12/2019; F170232A EXP 07/13/2019.",
      "more_code_info": ""
    }
  ]
}