{
  "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": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202557"
        ],
        "brand_name": [
          "BUSPIRONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUSPIRONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-200",
          "16729-203",
          "16729-289",
          "16729-201",
          "16729-202"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUSPIRONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "866018",
          "866083",
          "866090",
          "866094",
          "866111"
        ],
        "spl_id": [
          "4092e48b-b3d6-abf3-e063-6394a90afe61"
        ],
        "spl_set_id": [
          "3da22999-f5fb-49fd-acde-c3006598e985"
        ],
        "package_ndc": [
          "16729-203-12",
          "16729-203-01",
          "16729-203-59",
          "16729-203-16",
          "16729-203-17",
          "16729-289-12",
          "16729-289-01",
          "16729-289-59",
          "16729-289-16",
          "16729-289-17",
          "16729-200-01",
          "16729-200-16",
          "16729-200-17",
          "16729-201-01",
          "16729-201-16",
          "16729-201-17",
          "16729-202-01",
          "16729-202-16",
          "16729-202-17"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316729289016",
          "316729203012"
        ],
        "unii": [
          "207LT9J9OC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91657",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States including Puerto Rico and Canada",
      "recall_number": "D-0377-2023",
      "product_description": "BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 2;",
      "product_quantity": "10992 bottles",
      "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230302",
      "termination_date": "20240422",
      "report_date": "20230308",
      "code_info": "Batches: P2105483, Exp. Date 7/31/2024;",
      "more_code_info": ""
    }
  ]
}