{
  "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 II",
      "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": "78217",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0109-2018",
      "product_description": "Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles,  Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512",
      "product_quantity": "N/A",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products",
      "recall_initiation_date": "20170418",
      "center_classification_date": "20171213",
      "termination_date": "20180530",
      "report_date": "20171220",
      "code_info": "A lot # 160031A, A160031B; Exp. 11/17"
    }
  ]
}