{
  "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": "ISELIN",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA216436"
        ],
        "brand_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "generic_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "Biocon Pharma Inc."
        ],
        "product_ndc": [
          "70377-077",
          "70377-078",
          "70377-079",
          "70377-080"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATORVASTATIN CALCIUM TRIHYDRATE"
        ],
        "rxcui": [
          "259255",
          "617310",
          "617311",
          "617312"
        ],
        "spl_id": [
          "72b8b3f5-4658-80af-655c-87ce7966a5e6"
        ],
        "spl_set_id": [
          "5b839619-1805-c227-91bf-182f5b966ba4"
        ],
        "package_ndc": [
          "70377-077-11",
          "70377-077-13",
          "70377-077-12",
          "70377-078-11",
          "70377-078-13",
          "70377-078-12",
          "70377-079-11",
          "70377-079-12",
          "70377-079-13",
          "70377-080-11",
          "70377-080-12",
          "70377-080-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370377080111"
        ],
        "unii": [
          "48A5M73Z4Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96496",
      "recalling_firm": "BIOCON PHARMA INC",
      "address_1": "485 HWY 1 (S)",
      "address_2": "",
      "postal_code": "08830",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "U.S.A. nationwide",
      "recall_number": "D-0306-2025",
      "product_description": "Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13",
      "product_quantity": "2184 bottles",
      "reason_for_recall": "Failed dissolution specifications: lower than specifications",
      "recall_initiation_date": "20250317",
      "center_classification_date": "20250328",
      "report_date": "20250409",
      "code_info": "Lot#: AVC24035, Exp 03/31/26",
      "more_code_info": ""
    }
  ]
}