{
  "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": "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",
          "316729200011",
          "316729200165"
        ],
        "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-0376-2023",
      "product_description": "BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA",
      "product_quantity": "24,408 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: a) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024;",
      "more_code_info": ""
    }
  ]
}