{
  "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": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091226"
        ],
        "brand_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "generic_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-3950",
          "0378-3951",
          "0378-3952",
          "0378-3953"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATORVASTATIN CALCIUM TRIHYDRATE"
        ],
        "rxcui": [
          "259255",
          "617310",
          "617311",
          "617312"
        ],
        "spl_id": [
          "c94bf799-ec3d-4644-b1a2-3c7b3f612e19"
        ],
        "spl_set_id": [
          "d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d"
        ],
        "package_ndc": [
          "0378-3950-77",
          "0378-3950-05",
          "0378-3950-09",
          "0378-3950-07",
          "0378-3951-77",
          "0378-3951-05",
          "0378-3951-09",
          "0378-3951-07",
          "0378-3952-77",
          "0378-3952-05",
          "0378-3952-09",
          "0378-3952-07",
          "0378-3953-77",
          "0378-3953-05",
          "0378-3953-09",
          "0378-3953-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303783953779",
          "0303783952772",
          "0303783950778",
          "0303783951775"
        ],
        "unii": [
          "48A5M73Z4Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76750",
      "recalling_firm": "Mylan Pharmaceuticals Inc.",
      "address_1": "781 Chestnut Ridge Rd",
      "address_2": "",
      "postal_code": "26505-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0621-2017",
      "product_description": "Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV  26505 U.S.A.",
      "product_quantity": "452,269 bottles",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.",
      "recall_initiation_date": "20170320",
      "center_classification_date": "20170328",
      "termination_date": "20180126",
      "report_date": "20170405",
      "code_info": "Lot #: a) 3073782, 3073783, Exp 02/18; 3074915, 3074916, 3074917, Exp 03/18; 3074918, 3075572, Exp 04/18; 3075573, 3075574, Exp 05/18; 2007226, 3075894, Exp 06/18; 2007344, 2007345, 2007346, Exp 08/18; 2007451, 2007452, 2007453, 2007454, Exp 09/18; b) 3070840, Exp 10/17; 3073781, 3074911, Exp 02/18; 3074912, 3074913, 3074914, Exp 03/18; 3075570, 3075571, Exp 04/18; 3075892, Exp 05/18; 3075893, Exp 06/18; 2007341, 2007342, 2007343, 2007347, Exp 08/18; 2007456, Exp 10/18",
      "more_code_info": ""
    }
  ]
}