{
  "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": "2026-07-29",
    "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": [
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        ],
        "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": [
          "9TN87S3A3C",
          "57Y76R9ATQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88591",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-0822-2021",
      "product_description": "Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05",
      "product_quantity": "a) 31248 bottles; b) 300 bottles",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20210827",
      "center_classification_date": "20210921",
      "termination_date": "20231004",
      "report_date": "20210929",
      "code_info": "Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022",
      "more_code_info": ""
    }
  ]
}