{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Salisbury",
      "state": "MD",
      "country": "United States",
      "classification": "Class I",
      "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": "89854",
      "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": "E-Mail",
      "distribution_pattern": "Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.",
      "recall_number": "D-0767-2022",
      "product_description": "Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06",
      "product_quantity": "12,174 bottles",
      "reason_for_recall": "Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride",
      "recall_initiation_date": "20220308",
      "center_classification_date": "20220412",
      "termination_date": "20221115",
      "report_date": "20220406",
      "code_info": "Lot # 22P0036, Exp 12/2024"
    }
  ]
}