{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA076714"
        ],
        "brand_name": [
          "PRAVASTATIN SODIUM"
        ],
        "generic_name": [
          "PRAVASTATIN SODIUM"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-229",
          "55111-230",
          "55111-231",
          "55111-274"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRAVASTATIN SODIUM"
        ],
        "rxcui": [
          "904458",
          "904467",
          "904475",
          "904481"
        ],
        "spl_id": [
          "5f4e21ff-4bcc-df0d-a629-ba190d95edc0"
        ],
        "spl_set_id": [
          "99cc0546-bb2d-751e-edfd-1c15a1182e0c"
        ],
        "package_ndc": [
          "55111-229-30",
          "55111-229-90",
          "55111-229-01",
          "55111-229-05",
          "55111-230-30",
          "55111-230-90",
          "55111-230-01",
          "55111-230-05",
          "55111-231-30",
          "55111-231-90",
          "55111-231-01",
          "55111-231-05",
          "55111-274-30",
          "55111-274-90",
          "55111-274-01",
          "55111-274-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3M8608UQ61"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77734",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1038-2017",
      "product_description": "Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ  08540 USA.",
      "product_quantity": "544 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.",
      "recall_initiation_date": "20170711",
      "center_classification_date": "20170731",
      "termination_date": "20190401",
      "report_date": "20170809",
      "code_info": "Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18"
    }
  ]
}