{
  "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": "Jerusalem",
      "state": "N/A",
      "country": "Israel",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077369"
        ],
        "brand_name": [
          "IRBESARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "IRBESARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-8232",
          "0093-8238"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "IRBESARTAN"
        ],
        "rxcui": [
          "310792",
          "310793"
        ],
        "spl_id": [
          "af80b0d1-ba9d-4d3c-849c-6c7c1a7cfade"
        ],
        "spl_set_id": [
          "83f4acc1-697a-4770-b554-1b9a8fb5de74"
        ],
        "package_ndc": [
          "0093-8238-56",
          "0093-8238-98",
          "0093-8232-56",
          "0093-8232-98"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300938238569"
        ],
        "nui": [
          "N0000000070",
          "N0000175561",
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]",
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "J0E2756Z7N",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "72607",
      "recalling_firm": "Teva Pharmaceutical Industries",
      "address_1": "20 Kiryat HaMada Street,",
      "address_2": "Har Hozvim",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0521-2016",
      "product_description": "Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98",
      "product_quantity": "3536 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot AND/OR Exp Date.",
      "recall_initiation_date": "20151020",
      "center_classification_date": "20151217",
      "termination_date": "20161101",
      "report_date": "20151223",
      "code_info": "Lot #: 24I030, Exp 5/2017"
    }
  ]
}