{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA040268"
        ],
        "brand_name": [
          "PROCHLORPERAZINE MALEATE"
        ],
        "generic_name": [
          "PROCHLORPERAZINE MALEATE"
        ],
        "manufacturer_name": [
          "Jubilant Cadista Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "59746-113",
          "59746-115"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PROCHLORPERAZINE MALEATE"
        ],
        "rxcui": [
          "198365",
          "312635"
        ],
        "spl_id": [
          "15ccaf96-5c2f-45cb-992c-99f5458da55b"
        ],
        "spl_set_id": [
          "b05bc20e-cd19-ab40-1ad0-84a115d6d69e"
        ],
        "package_ndc": [
          "59746-113-06",
          "59746-113-10",
          "59746-115-06",
          "59746-115-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359746113063",
          "0359746115067"
        ],
        "unii": [
          "I1T8O1JTL6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91412",
      "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 in the USA.",
      "recall_number": "D-0096-2023",
      "product_description": "Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06",
      "product_quantity": "14,061 bottles",
      "reason_for_recall": "Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.",
      "recall_initiation_date": "20221227",
      "center_classification_date": "20230105",
      "termination_date": "20231205",
      "report_date": "20230111",
      "code_info": "Lot#: 21P0336, Exp: 04/2023"
    }
  ]
}