{
  "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": "Ongoing",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205932"
        ],
        "brand_name": [
          "PITAVASTATIN"
        ],
        "generic_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "AvKARE"
        ],
        "product_ndc": [
          "42291-905",
          "42291-906",
          "42291-907"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "rxcui": [
          "861643",
          "861648",
          "861652"
        ],
        "spl_id": [
          "48843604-c6e9-1aec-e063-6294a90aea80"
        ],
        "spl_set_id": [
          "0f11ee80-871e-4f13-e063-6394a90af19d"
        ],
        "package_ndc": [
          "42291-906-90",
          "42291-907-90",
          "42291-905-90"
        ],
        "original_packager_product_ndc": [
          "0480-3632",
          "0480-3633",
          "0480-3631"
        ],
        "unii": [
          "IYD54XEG3W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97160",
      "recalling_firm": "AvKARE",
      "address_1": "615 N 1st St",
      "address_2": "",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0528-2025",
      "product_description": "Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478.  NDC: 42291-905-90",
      "product_quantity": "1,560 bottles",
      "reason_for_recall": "Failed Impurity/Degradation Specifications",
      "recall_initiation_date": "20250626",
      "center_classification_date": "20250716",
      "report_date": "20250709",
      "code_info": "Lot, expiry:  Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;",
      "more_code_info": ""
    }
  ]
}