{
  "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": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207068"
        ],
        "brand_name": [
          "PRAVASTATIN SODIUM"
        ],
        "generic_name": [
          "PRAVASTATIN SODIUM"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-008",
          "16729-009",
          "16729-010",
          "16729-011"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRAVASTATIN SODIUM"
        ],
        "rxcui": [
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          "904467",
          "904475",
          "904481"
        ],
        "spl_id": [
          "438f9112-0851-75e1-e063-6294a90a675c"
        ],
        "spl_set_id": [
          "6c011348-a236-47d3-bbef-3e0b956dd080"
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        "package_ndc": [
          "16729-008-15",
          "16729-008-16",
          "16729-008-17",
          "16729-009-15",
          "16729-009-16",
          "16729-009-17",
          "16729-010-15",
          "16729-010-16",
          "16729-010-17",
          "16729-011-15",
          "16729-011-16",
          "16729-011-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3M8608UQ61"
        ],
        "upc": [
          "316729011150"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91657",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States including Puerto Rico and Canada",
      "recall_number": "D-0424-2023",
      "product_description": "Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0",
      "product_quantity": "1970 bottles",
      "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230302",
      "termination_date": "20240422",
      "report_date": "20230308",
      "code_info": "Batches:  R2201233, Exp. Date 4/30/2024",
      "more_code_info": ""
    }
  ]
}