{
  "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": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078728"
        ],
        "brand_name": [
          "GLIPIZIDE AND METFORMIN HCL"
        ],
        "generic_name": [
          "GLIPIZIDE AND METFORMIN HCL"
        ],
        "manufacturer_name": [
          "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "23155-115",
          "23155-116",
          "23155-117"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GLIPIZIDE",
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "861731",
          "861736",
          "861740"
        ],
        "spl_id": [
          "f6a0152a-4cab-48f9-b14c-31c662f676ed"
        ],
        "spl_set_id": [
          "94a7f96e-2ed1-432d-bc6a-5840863816e1"
        ],
        "package_ndc": [
          "23155-115-01",
          "23155-115-10",
          "23155-116-01",
          "23155-116-10",
          "23155-117-01",
          "23155-117-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175608",
          "M0020795"
        ],
        "pharm_class_epc": [
          "Sulfonylurea [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfonylurea Compounds [CS]"
        ],
        "unii": [
          "786Z46389E",
          "X7WDT95N5C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70845",
      "recalling_firm": "Heritage Pharmaceuticals, Inc.",
      "address_1": "12 Christopher Way Ste 300",
      "address_2": "N/A",
      "postal_code": "07724-3331",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide including Puerto Rico.",
      "recall_number": "D-0436-2015",
      "product_description": "GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only.  Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.",
      "product_quantity": "6,816 Bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.",
      "recall_initiation_date": "20150325",
      "center_classification_date": "20150407",
      "termination_date": "20170515",
      "report_date": "20150415",
      "code_info": "Lot #:18020994, Expiry: October 2015; Lot #: 18021311, Expiry: November 2015."
    }
  ]
}