{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "North Wales",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078407"
        ],
        "brand_name": [
          "FLUVASTATIN"
        ],
        "generic_name": [
          "FLUVASTATIN"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-7442",
          "0093-7443"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUVASTATIN SODIUM"
        ],
        "rxcui": [
          "310404",
          "310405"
        ],
        "spl_id": [
          "1fb50b66-e9d0-4fd1-928e-b37c4fff4ccc"
        ],
        "spl_set_id": [
          "aad8b373-0aec-4efb-8e61-3d8114b31127"
        ],
        "package_ndc": [
          "0093-7442-56",
          "0093-7442-01",
          "0093-7443-56",
          "0093-7443-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300937443568",
          "0300937442561"
        ],
        "unii": [
          "PYF7O1FV7F"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68441",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "1090 Horsham Rd",
      "address_2": "",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands",
      "recall_number": "D-1430-2014",
      "product_description": "Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56",
      "product_quantity": "8,472 Bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.",
      "recall_initiation_date": "20140529",
      "center_classification_date": "20140710",
      "termination_date": "20150309",
      "report_date": "20140716",
      "code_info": "Lot #: F47008, Exp. 7/2015",
      "more_code_info": ""
    }
  ]
}