{
  "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": "Terminated",
      "city": "La Vergne",
      "state": "TN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA077565"
        ],
        "brand_name": [
          "ZIPRASIDONE"
        ],
        "generic_name": [
          "ZIPRASIDONE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-6269",
          "0904-6270",
          "0904-6271",
          "0904-6272"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ZIPRASIDONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313776",
          "313777",
          "313778",
          "314286"
        ],
        "spl_id": [
          "11aa05a7-d934-4932-990a-da13164d3825"
        ],
        "spl_set_id": [
          "ca55c149-5b9a-4144-b586-37cb5e84dc4e"
        ],
        "package_ndc": [
          "0904-6269-08",
          "0904-6269-45",
          "0904-6270-08",
          "0904-6270-45",
          "0904-6271-08",
          "0904-6271-45",
          "0904-6272-08",
          "0904-6272-45"
        ],
        "original_packager_product_ndc": [
          "55111-256",
          "55111-257",
          "55111-258",
          "55111-259"
        ],
        "unii": [
          "216X081ORU"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92463",
      "recalling_firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories",
      "address_1": "341 Mason Rd",
      "address_2": "",
      "postal_code": "37086-3606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0893-2023",
      "product_description": "ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08",
      "product_quantity": "unknown",
      "reason_for_recall": "Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.",
      "recall_initiation_date": "20230531",
      "center_classification_date": "20230705",
      "termination_date": "20240702",
      "report_date": "20230628",
      "code_info": "Lot: T04769 Exp. 2024/12",
      "more_code_info": ""
    }
  ]
}