{
  "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": "Yunlin County",
      "state": "",
      "country": "Taiwan",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205932"
        ],
        "brand_name": [
          "PITAVASTATIN"
        ],
        "generic_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0480-3631",
          "0480-3632",
          "0480-3633"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "rxcui": [
          "861643",
          "861648",
          "861652"
        ],
        "spl_id": [
          "191b4856-1662-a7b8-e063-6394a90a2c56"
        ],
        "spl_set_id": [
          "fac09182-dcf2-1770-e053-6394a90af50c"
        ],
        "package_ndc": [
          "0480-3632-98",
          "0480-3633-98",
          "0480-3631-98"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0304803633985",
          "0304803631981",
          "0304803632988"
        ],
        "unii": [
          "IYD54XEG3W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97076",
      "recalling_firm": "Orient Pharma Co., Ltd. Yunlin Plant",
      "address_1": "No. 8 Kehu 1st Rd.",
      "address_2": "Huwei Township",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NJ",
      "recall_number": "D-0526-2025",
      "product_description": "Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.",
      "product_quantity": "57504 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications.",
      "recall_initiation_date": "20250611",
      "center_classification_date": "20250716",
      "report_date": "20250709",
      "code_info": "P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.",
      "more_code_info": ""
    }
  ]
}