{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208066"
        ],
        "brand_name": [
          "LURASIDONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "LURASIDONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-578",
          "47335-684",
          "47335-639",
          "47335-685",
          "47335-579"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LURASIDONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1040031",
          "1040041",
          "1235247",
          "1297278",
          "1431235"
        ],
        "spl_id": [
          "532e9d94-9135-b5cb-e063-6394a90a5f66"
        ],
        "spl_set_id": [
          "6d97d871-66d3-4ed8-bbc5-0620e9f69ae5"
        ],
        "package_ndc": [
          "47335-578-83",
          "47335-578-81",
          "47335-578-13",
          "47335-684-83",
          "47335-684-81",
          "47335-684-13",
          "47335-639-83",
          "47335-639-81",
          "47335-639-13",
          "47335-685-83",
          "47335-685-81",
          "47335-685-13",
          "47335-579-83",
          "47335-579-81",
          "47335-579-13"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "O0P4I5851I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93820",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0267-2024",
      "product_description": "Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by:  Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.",
      "product_quantity": "9,408 bottles",
      "reason_for_recall": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
      "recall_initiation_date": "20240118",
      "center_classification_date": "20240125",
      "report_date": "20240131",
      "code_info": "Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024"
    }
  ]
}