{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "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": "94899",
      "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": "",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0612-2024",
      "product_description": "Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,",
      "product_quantity": "a) 145,800 bottles;  b) 1,368 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: results below specifications",
      "recall_initiation_date": "20240628",
      "center_classification_date": "20240718",
      "report_date": "20240724",
      "code_info": "Lot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024",
      "more_code_info": ""
    }
  ]
}