{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078314"
        ],
        "brand_name": [
          "NAPROXEN SODIUM"
        ],
        "generic_name": [
          "NAPROXEN SODIUM"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-178",
          "68462-188",
          "68462-189",
          "68462-190",
          "68462-179"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NAPROXEN SODIUM"
        ],
        "rxcui": [
          "198012",
          "198013",
          "198014",
          "849398",
          "849431"
        ],
        "spl_id": [
          "16372549-a419-4920-a200-5128017570ed"
        ],
        "spl_set_id": [
          "6c5bb008-e66f-4ef0-bf84-aca7eb5983e9"
        ],
        "package_ndc": [
          "68462-188-01",
          "68462-188-05",
          "68462-189-01",
          "68462-189-05",
          "68462-190-30",
          "68462-190-50",
          "68462-190-01",
          "68462-190-05",
          "68462-178-01",
          "68462-178-05",
          "68462-179-01",
          "68462-179-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462189016",
          "0368462178010",
          "0368462179017",
          "0368462188019",
          "0368462190012"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "57Y76R9ATQ",
          "9TN87S3A3C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63264",
      "recalling_firm": "Glenmark Generics Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1701-2012",
      "product_description": "NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.",
      "product_quantity": "unknown",
      "reason_for_recall": "Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.",
      "recall_initiation_date": "20120706",
      "center_classification_date": "20120927",
      "termination_date": "20150813",
      "report_date": "20121003",
      "code_info": "Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.",
      "more_code_info": ""
    }
  ]
}