{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077555"
        ],
        "brand_name": [
          "TIAGABINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "TIAGABINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-200",
          "62756-224"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TIAGABINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1299911",
          "1299917"
        ],
        "spl_id": [
          "57975e74-e45b-4fd9-9718-bfc9690acae5"
        ],
        "spl_set_id": [
          "7eeb2d81-c5d7-46a0-aa5c-149b55df71bd"
        ],
        "package_ndc": [
          "62756-200-83",
          "62756-200-18",
          "62756-224-83",
          "62756-224-88",
          "62756-224-08",
          "62756-224-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362756200838",
          "0362756224834"
        ],
        "unii": [
          "DQH6T6D8OY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92671",
      "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": "Distributed nationwide in the USA.",
      "recall_number": "D-0914-2023",
      "product_description": "Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#:  62756-200-83",
      "product_quantity": "8,880 30-count bottles",
      "reason_for_recall": "Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing",
      "recall_initiation_date": "20230710",
      "center_classification_date": "20230711",
      "termination_date": "20231218",
      "report_date": "20230719",
      "code_info": "Lot HAC3339A, Expires 07/2023",
      "more_code_info": ""
    }
  ]
}