{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Drugs",
      "event_id": "80828",
      "recalling_firm": "AVKARE Inc.",
      "address_1": "615 N 1st St",
      "address_2": "N/A",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-1131-2018",
      "product_description": "Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478",
      "product_quantity": "728 cartons (36,400 tablets)",
      "reason_for_recall": "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.",
      "recall_initiation_date": "20180814",
      "center_classification_date": "20180828",
      "termination_date": "20200507",
      "report_date": "20180905",
      "code_info": "Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019"
    }
  ]
}