{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077987"
        ],
        "brand_name": [
          "PRAVASTATIN SODIUM"
        ],
        "generic_name": [
          "PRAVASTATIN SODIUM"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-195",
          "68462-196",
          "68462-197",
          "68462-198"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRAVASTATIN SODIUM"
        ],
        "rxcui": [
          "904458",
          "904467",
          "904475",
          "904481"
        ],
        "spl_id": [
          "a6e006b3-4256-4cbb-8ad1-b71f363430cd"
        ],
        "spl_set_id": [
          "6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4"
        ],
        "package_ndc": [
          "68462-195-90",
          "68462-195-05",
          "68462-196-90",
          "68462-196-05",
          "68462-197-90",
          "68462-197-05",
          "68462-198-90",
          "68462-198-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462195901",
          "0368462198902"
        ],
        "unii": [
          "3M8608UQ61"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82461",
      "recalling_firm": "Glenmark Pharmaceuticals 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 in the USA",
      "recall_number": "D-1120-2019",
      "product_description": "Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India.   Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05",
      "product_quantity": "2076 500-count Bottles",
      "reason_for_recall": "Presence Of  Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.",
      "recall_initiation_date": "20190325",
      "center_classification_date": "20190411",
      "termination_date": "20200914",
      "report_date": "20190417",
      "code_info": "Lot 17181491 Exp. Aug. 2021"
    }
  ]
}