{
  "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": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076122"
        ],
        "brand_name": [
          "MIRTAZAPINE"
        ],
        "generic_name": [
          "MIRTAZAPINE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-3515",
          "0378-3530",
          "0378-3545"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MIRTAZAPINE"
        ],
        "rxcui": [
          "311725",
          "311726",
          "314111"
        ],
        "spl_id": [
          "681d9ec4-046b-4c0e-b85f-2468620c724b"
        ],
        "spl_set_id": [
          "711aa80b-8fc6-49e6-9494-3db31d9b53a4"
        ],
        "package_ndc": [
          "0378-3515-70",
          "0378-3515-93",
          "0378-3515-01",
          "0378-3515-10",
          "0378-3530-70",
          "0378-3530-93",
          "0378-3530-01",
          "0378-3530-05",
          "0378-3545-70",
          "0378-3545-93",
          "0378-3545-01",
          "0378-3545-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303783545936",
          "0303783530932"
        ],
        "unii": [
          "A051Q2099Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76357",
      "recalling_firm": "Mylan Pharmaceuticals Inc.",
      "address_1": "781 Chestnut Ridge Rd",
      "address_2": "N/A",
      "postal_code": "26505-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0492-2017",
      "product_description": "Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV",
      "product_quantity": "37,445 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle",
      "recall_initiation_date": "20170119",
      "center_classification_date": "20170308",
      "termination_date": "20170712",
      "report_date": "20170315",
      "code_info": "a) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019  b) 3078937 (NDC 0378-3545-01), exp August 2019  c) 3078936 (0378-3545-05), exp August 2019"
    }
  ]
}