{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hasbrouck Heights",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078635"
        ],
        "brand_name": [
          "BISOPROLOL FUMARATE"
        ],
        "generic_name": [
          "BISOPROLOL FUMARATE"
        ],
        "manufacturer_name": [
          "Unichem Pharmaceuticals (USA), Inc."
        ],
        "product_ndc": [
          "29300-126",
          "29300-127"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BISOPROLOL FUMARATE"
        ],
        "rxcui": [
          "854901",
          "854905"
        ],
        "spl_id": [
          "958d523d-b040-4475-ad89-6278e5cf0f60"
        ],
        "spl_set_id": [
          "4f20df45-3f9c-4a91-b394-e93a08111ec3"
        ],
        "package_ndc": [
          "29300-126-13",
          "29300-126-01",
          "29300-126-05",
          "29300-127-13",
          "29300-127-01",
          "29300-127-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0329300126136",
          "0329300127133"
        ],
        "unii": [
          "UR59KN573L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78218",
      "recalling_firm": "Unichem Pharmaceuticals Usa Inc",
      "address_1": "777 Terrace Ave",
      "address_2": "Suite 102",
      "postal_code": "07604-3102",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide",
      "recall_number": "D-0010-2018",
      "product_description": "Bisoprolol Fumarate tablets,  5 mg,  30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.",
      "product_quantity": "96,876 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity  was observed during the 18 month stability testing.",
      "recall_initiation_date": "20171002",
      "center_classification_date": "20171018",
      "termination_date": "20180913",
      "report_date": "20171025",
      "code_info": "Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp  03/31/2018.",
      "more_code_info": ""
    }
  ]
}