{
  "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": "Rockford",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076122"
        ],
        "brand_name": [
          "MIRTAZAPINE"
        ],
        "generic_name": [
          "MIRTAZAPINE"
        ],
        "manufacturer_name": [
          "Mylan Institutional Inc."
        ],
        "product_ndc": [
          "51079-086",
          "51079-087",
          "51079-088"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MIRTAZAPINE"
        ],
        "rxcui": [
          "311725",
          "311726",
          "314111"
        ],
        "spl_id": [
          "3a87423c-fbbb-b2a4-e063-6394a90a0db3"
        ],
        "spl_set_id": [
          "6837b69b-2f86-42cf-b48d-b4a3c7b5413f"
        ],
        "package_ndc": [
          "51079-086-01",
          "51079-086-20",
          "51079-087-01",
          "51079-087-20",
          "51079-088-01",
          "51079-088-20"
        ],
        "original_packager_product_ndc": [
          "0378-3515",
          "0378-3530",
          "0378-3545"
        ],
        "unii": [
          "A051Q2099Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76463",
      "recalling_firm": "Mylan Institutional, Inc. (d.b.a. UDL Laboratories)",
      "address_1": "1718 Northrock Ct",
      "address_2": "N/A",
      "postal_code": "61103-1201",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0493-2017",
      "product_description": "Mirtazapine Tablets, USP, 45 mg.  Rx only, 100 Tablets (10 X 10).  Manufactured by:  Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20",
      "product_quantity": "58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled",
      "recall_initiation_date": "20170127",
      "center_classification_date": "20170308",
      "termination_date": "20190315",
      "report_date": "20170315",
      "code_info": "Batch #3083289; Exp. Date 12/2018"
    }
  ]
}