{
  "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": [
          "ANDA203154"
        ],
        "brand_name": [
          "ALLOPURINOL"
        ],
        "generic_name": [
          "ALLOPURINOL"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-134",
          "16729-135"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ALLOPURINOL"
        ],
        "rxcui": [
          "197319",
          "197320"
        ],
        "spl_id": [
          "40820fd2-3759-d43f-e063-6394a90a7c93"
        ],
        "spl_set_id": [
          "682dd8b8-fc6e-47c5-95b7-82d7ad96b750"
        ],
        "package_ndc": [
          "16729-134-10",
          "16729-134-01",
          "16729-134-16",
          "16729-134-17",
          "16729-135-10",
          "16729-135-01",
          "16729-135-16",
          "16729-135-17"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175698",
          "N0000000206"
        ],
        "pharm_class_epc": [
          "Xanthine Oxidase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Xanthine Oxidase Inhibitors [MoA]"
        ],
        "unii": [
          "63CZ7GJN5I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91499",
      "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": "Nationwide in the USA",
      "recall_number": "D-0168-2023",
      "product_description": "Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01",
      "product_quantity": "87,576 bottles",
      "reason_for_recall": "Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.",
      "recall_initiation_date": "20230112",
      "center_classification_date": "20230120",
      "termination_date": "20240423",
      "report_date": "20230201",
      "code_info": "Lots: R2200455, R2200456 Exp. 03/2025",
      "more_code_info": ""
    }
  ]
}