{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dawsonville",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091629"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Direct_Rx"
        ],
        "product_ndc": [
          "72189-012",
          "72189-098",
          "72189-129",
          "72189-139",
          "72189-167"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "LOSARTAN POTASSIUM"
        ],
        "rxcui": [
          "979464",
          "979468",
          "979471"
        ],
        "spl_id": [
          "2becfaea-c7d6-ec34-e063-6294a90af5b3"
        ],
        "spl_set_id": [
          "8de04bf2-83dd-c494-e053-2a95a90abade"
        ],
        "package_ndc": [
          "72189-012-90",
          "72189-098-90",
          "72189-129-90",
          "72189-129-30",
          "72189-139-30",
          "72189-139-90",
          "72189-167-30",
          "72189-167-90"
        ],
        "original_packager_product_ndc": [
          "65862-468",
          "0093-7369",
          "59746-337",
          "59746-339",
          "68180-216"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "0J48LPH2TH",
          "3ST302B24A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90161",
      "recalling_firm": "Direct Rx",
      "address_1": "94 Worldwide Dr",
      "address_2": "N/A",
      "postal_code": "30534-6828",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AL, GA, FL, LA",
      "recall_number": "D-0971-2022",
      "product_description": "Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90",
      "product_quantity": "81 bottles",
      "reason_for_recall": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
      "recall_initiation_date": "20220505",
      "center_classification_date": "20220527",
      "termination_date": "20231005",
      "report_date": "20220608",
      "code_info": "a) 30-count bottles-    Lot: 11MY2103 Exp. 11/30/22  Lot: 05JA2106 Exp. 6/30/22      b) 90-count bottles-       Lot: 20MY2115 Exp. 11/30/22  Lot: 22JU2118 Exp. 12/31/22  Lot: 29JY2113 Exp. 12/31/22  Lot: 13SE2113 Exp. 2/28/23  Lot: 05JA2106 Exp. 6/30/22"
    }
  ]
}