{
  "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 III",
      "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": "64995",
      "recalling_firm": "Glenmark Generics 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-330-2013",
      "product_description": "Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India  Manufactured for :Glenmark Generics USA Mahwah, NJ 07430",
      "product_quantity": "246,528 bottles",
      "reason_for_recall": "Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.",
      "recall_initiation_date": "20130405",
      "center_classification_date": "20130516",
      "termination_date": "20141009",
      "report_date": "20130522",
      "code_info": "Lot # 02121059  Exp 03/15  Lot # 02121484  Exp 04/15  Lot # 02121530  Exp 04/15  Lot#  02121665  Exp     05/15  Lot#  02121669  Exp     05/15  Lot#  02121689  Exp     05/15  Lot#  02121705  Exp 05/15  Lot#  02123434  Exp 10/15  Lot#  02123446  Exp 10/15  Lot#  02123633  Exp 11/15  Lot#  02123677  Exp 11/15  Lot#  02123685  Exp 11/15  Lot#  02123695  Exp 11/15  Lot#  02123823  Exp 11/15  Lot#  02123833  Exp 11/15  Lot#  02123836  Exp 11/15  Lot#  02123853  Exp 11/15  Lot#  02123859  Exp 11/15  Lot#  02130021  Exp 12/15  Lot#  02130059  Exp 12/15  Lot#  02130079  Exp 12/15",
      "more_code_info": ""
    }
  ]
}