{
  "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"
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        "spl_id": [
          "191b4856-1662-a7b8-e063-6394a90a2c56"
        ],
        "spl_set_id": [
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        "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-0527-2025",
      "product_description": "Pitavastatin Tablets, 1 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 0480-3631-98.",
      "product_quantity": "20618 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications.",
      "recall_initiation_date": "20250611",
      "center_classification_date": "20250716",
      "report_date": "20250709",
      "code_info": "P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.",
      "more_code_info": ""
    }
  ]
}