{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA079106"
        ],
        "brand_name": [
          "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Unichem Pharmaceuticals (USA), Inc."
        ],
        "product_ndc": [
          "29300-187",
          "29300-188",
          "29300-189"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "BISOPROLOL FUMARATE"
        ],
        "rxcui": [
          "854908",
          "854916",
          "854919"
        ],
        "spl_id": [
          "057844aa-5d7e-4e83-b71f-9072d2a2b93d"
        ],
        "spl_set_id": [
          "b9ee689a-ea12-435d-b01c-70d45891e62f"
        ],
        "package_ndc": [
          "29300-187-13",
          "29300-187-01",
          "29300-187-05",
          "29300-187-10",
          "29300-188-13",
          "29300-188-01",
          "29300-188-05",
          "29300-188-10",
          "29300-189-13",
          "29300-189-01",
          "29300-189-05",
          "29300-189-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "UR59KN573L",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98323",
      "recalling_firm": "Unichem Pharmaceuticals USA Inc.",
      "address_1": "1 Tower Center Blvd Ste 2200",
      "address_2": "N/A",
      "postal_code": "08816-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide and PR.",
      "recall_number": "D-0301-2026",
      "product_description": "Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01",
      "product_quantity": "N/A",
      "reason_for_recall": "cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.",
      "recall_initiation_date": "20260121",
      "center_classification_date": "20260130",
      "report_date": "20260211",
      "code_info": "Lot # GBHL24005A, Exp Date: 09/2026"
    }
  ]
}