{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078470"
        ],
        "brand_name": [
          "ACARBOSE"
        ],
        "generic_name": [
          "ACARBOSE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-0140",
          "0054-0141",
          "0054-0142"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACARBOSE"
        ],
        "rxcui": [
          "199149",
          "199150",
          "200132"
        ],
        "spl_id": [
          "2d7f6918-65c3-4db3-b775-b74e1e637cea"
        ],
        "spl_set_id": [
          "352dd336-d3f9-4ac5-a000-91d3aef7aca3"
        ],
        "package_ndc": [
          "0054-0140-25",
          "0054-0141-20",
          "0054-0141-25",
          "0054-0142-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300540140250"
        ],
        "nui": [
          "N0000000166",
          "N0000175559"
        ],
        "pharm_class_moa": [
          "alpha Glucosidase Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "alpha-Glucosidase Inhibitor [EPC]"
        ],
        "unii": [
          "T58MSI464G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70990",
      "recalling_firm": "Boehringer Ingelheim Roxane Inc",
      "address_1": "1809 Wilson Rd",
      "address_2": "",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1085-2015",
      "product_description": "Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25",
      "product_quantity": "a) 575 Blister Packs, b) 12,802 Bottles",
      "reason_for_recall": "Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.",
      "recall_initiation_date": "20150402",
      "center_classification_date": "20150527",
      "termination_date": "20160219",
      "report_date": "20150603",
      "code_info": "a) Lot # 460073A Exp 04/2016  b) Lot # 460073B  Exp 04/2016",
      "more_code_info": ""
    }
  ]
}