{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Caguas",
      "state": "PR",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090596"
        ],
        "brand_name": [
          "TACROLIMUS"
        ],
        "generic_name": [
          "TACROLIMUS"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-2045",
          "0378-2046",
          "0378-2047"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TACROLIMUS"
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        "rxcui": [
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          "198378",
          "313190"
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        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "0378-2045-01",
          "0378-2046-01",
          "0378-2047-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303782046014",
          "0303782045017",
          "0303782047011"
        ],
        "unii": [
          "WM0HAQ4WNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62454",
      "recalling_firm": "Mylan LLC.",
      "address_1": "Road #156, Km. 58.8, Lot 24B",
      "address_2": "N/A",
      "postal_code": "00725",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Natiowide",
      "recall_number": "D-066-2013",
      "product_description": "Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01",
      "product_quantity": "15181 bottles.",
      "reason_for_recall": "Failed USP Content Uniformity Requirements: OOS result reported on retained samples.",
      "recall_initiation_date": "20120629",
      "center_classification_date": "20121126",
      "termination_date": "20170413",
      "report_date": "20121205",
      "code_info": "Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13  2002157 Exp. 9/12"
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}