{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sacramento",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213853"
        ],
        "brand_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "generic_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "NIVAGEN PHARMACEUTICALS, INC."
        ],
        "product_ndc": [
          "75834-255",
          "75834-256",
          "75834-257",
          "75834-258"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATORVASTATIN"
        ],
        "rxcui": [
          "259255",
          "617310",
          "617311",
          "617312"
        ],
        "spl_id": [
          "4580fe3c-b524-3a14-e063-6294a90a34d3"
        ],
        "spl_set_id": [
          "7c58bf4a-4a92-4db8-89bc-4de1b5831efc"
        ],
        "package_ndc": [
          "75834-256-90",
          "75834-256-01",
          "75834-256-05",
          "75834-256-50",
          "75834-255-90",
          "75834-255-01",
          "75834-255-05",
          "75834-255-50",
          "75834-257-90",
          "75834-257-50",
          "75834-257-25",
          "75834-257-01",
          "75834-258-90",
          "75834-258-50",
          "75834-258-02",
          "75834-258-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0375834258027",
          "0375834257501",
          "0375834255903",
          "0375834256016"
        ],
        "nui": [
          "N0000175589",
          "N0000000121"
        ],
        "pharm_class_epc": [
          "HMG-CoA Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "A0JWA85V8F"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95418",
      "recalling_firm": "Nivagen Pharmaceuticals Inc",
      "address_1": "3100 Fite Cir",
      "address_2": "N/A",
      "postal_code": "95827-1805",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0001-2025",
      "product_description": "Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.",
      "product_quantity": "2328 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.",
      "recall_initiation_date": "20240924",
      "center_classification_date": "20241002",
      "termination_date": "20260701",
      "report_date": "20241009",
      "code_info": "Lot #: U24T0408A, Exp: 03/31/2026"
    }
  ]
}