{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA090383"
        ],
        "brand_name": [
          "SIMVASTATIN"
        ],
        "generic_name": [
          "SIMVASTATIN"
        ],
        "manufacturer_name": [
          "Micro Labs Limited"
        ],
        "product_ndc": [
          "42571-005",
          "42571-010",
          "42571-020",
          "42571-040",
          "42571-080"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SIMVASTATIN"
        ],
        "rxcui": [
          "198211",
          "200345",
          "312961",
          "312962",
          "314231"
        ],
        "spl_id": [
          "0369d423-9ef2-0191-e063-6294a90a55e7"
        ],
        "spl_set_id": [
          "5c1c694c-4b08-469e-b538-08e69df06146"
        ],
        "package_ndc": [
          "42571-010-30",
          "42571-010-60",
          "42571-010-90",
          "42571-010-05",
          "42571-010-10",
          "42571-005-30",
          "42571-005-60",
          "42571-005-90",
          "42571-005-05",
          "42571-005-10",
          "42571-020-30",
          "42571-020-60",
          "42571-020-90",
          "42571-020-05",
          "42571-020-10",
          "42571-040-30",
          "42571-040-60",
          "42571-040-90",
          "42571-040-05",
          "42571-040-10",
          "42571-080-30",
          "42571-080-60",
          "42571-080-90",
          "42571-080-05",
          "42571-080-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0342571010300",
          "0342571040307",
          "0342571020309",
          "0342571005306",
          "0342571080303"
        ],
        "nui": [
          "N0000175589",
          "N0000000121"
        ],
        "pharm_class_epc": [
          "HMG-CoA Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "AGG2FN16EV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69928",
      "recalling_firm": "Micro Labs Usa, Inc                                    S",
      "address_1": "104 Carnegie Ctr",
      "address_2": "Te 216",
      "postal_code": "08540-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-0409-2015",
      "product_description": "Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,   Princeton, NJ 08540 NDC 42571-080-90.",
      "product_quantity": "13464 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Product failed a known impurity specification.",
      "recall_initiation_date": "20141204",
      "center_classification_date": "20150311",
      "termination_date": "20180425",
      "report_date": "20150318",
      "code_info": "Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015"
    }
  ]
}