{
  "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": "Salisbury",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040659"
        ],
        "brand_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "MECLIZINE HYDROCLORIDE"
        ],
        "manufacturer_name": [
          "Jubilant Cadista Pharmacuticals Inc."
        ],
        "product_ndc": [
          "59746-121",
          "59746-122"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "995624",
          "995666"
        ],
        "spl_id": [
          "ead33f00-e158-464f-953f-ab5a9a391199"
        ],
        "spl_set_id": [
          "9350fefc-9c00-182c-c3a9-044d4a40856f"
        ],
        "package_ndc": [
          "59746-122-06",
          "59746-122-10",
          "59746-121-06",
          "59746-121-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359746121068",
          "0359746122065"
        ],
        "unii": [
          "HDP7W44CIO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78461",
      "recalling_firm": "Jubilant Cadista Pharmaceuticals, Inc.",
      "address_1": "207 Kiley Dr",
      "address_2": "N/A",
      "postal_code": "21801-2249",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0082-2018",
      "product_description": "Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06",
      "product_quantity": "744 bottles",
      "reason_for_recall": "Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.",
      "recall_initiation_date": "20171030",
      "center_classification_date": "20171116",
      "termination_date": "20200212",
      "report_date": "20171122",
      "code_info": "Lot # 17P0430, Exp 05/19"
    }
  ]
}