{
  "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": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206251"
        ],
        "brand_name": [
          "ARIPIPRAZOLE"
        ],
        "generic_name": [
          "ARIPIPRAZOLE"
        ],
        "manufacturer_name": [
          "Accord Healthcare, Inc."
        ],
        "product_ndc": [
          "16729-278",
          "16729-279",
          "16729-280",
          "16729-281",
          "16729-282",
          "16729-283"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ARIPIPRAZOLE"
        ],
        "rxcui": [
          "349490",
          "349545",
          "349547",
          "349553",
          "402131",
          "602964"
        ],
        "spl_id": [
          "40825d37-d601-2272-e063-6294a90af90d"
        ],
        "spl_set_id": [
          "85cc7d25-414b-4b6f-a03a-48af908a16a1"
        ],
        "package_ndc": [
          "16729-278-10",
          "16729-278-01",
          "16729-278-16",
          "16729-278-46",
          "16729-279-10",
          "16729-279-01",
          "16729-279-16",
          "16729-279-46",
          "16729-280-10",
          "16729-280-01",
          "16729-280-16",
          "16729-280-46",
          "16729-281-10",
          "16729-281-01",
          "16729-281-16",
          "16729-281-46",
          "16729-282-10",
          "16729-282-01",
          "16729-282-16",
          "16729-282-46",
          "16729-283-10",
          "16729-283-01",
          "16729-283-16",
          "16729-283-46"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "82VFR53I78"
        ],
        "upc": [
          "316729283106",
          "316729283014"
        ]
      },
      "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-0370-2023",
      "product_description": "Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle,  NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle,  NDC 16729-283-01, UPC 3 16729 28301 4; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India",
      "product_quantity": "88,728 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) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp. Date 7/31/2024; P2107447, Exp. Date 10/31/2024; P2203388 Exp. Date 5/31/2025;   b) P2101859 Exp. Date 2/28/2023; P2107056, Exp. Date 10/31/2023; P2203066, Exp. Date 5/31/2024; P2206130, Exp. Date 8/31/2024;",
      "more_code_info": ""
    }
  ]
}