{
  "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": "Completed",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA200484"
        ],
        "brand_name": [
          "NIACIN"
        ],
        "generic_name": [
          "NIACIN"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-539",
          "47335-614",
          "47335-613"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NIACIN"
        ],
        "rxcui": [
          "1098134",
          "1098141",
          "1098143"
        ],
        "spl_id": [
          "bc18daa3-5321-43bd-9d00-dabd9adac571"
        ],
        "spl_set_id": [
          "8e290f96-e8c6-47fd-863f-1c9480f28d9b"
        ],
        "package_ndc": [
          "47335-539-83",
          "47335-539-81",
          "47335-539-88",
          "47335-539-08",
          "47335-539-18",
          "47335-614-83",
          "47335-614-81",
          "47335-614-88",
          "47335-614-18",
          "47335-613-83",
          "47335-613-81",
          "47335-613-88",
          "47335-613-08",
          "47335-613-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335613810",
          "0347335614817",
          "0347335539813"
        ],
        "nui": [
          "N0000175594",
          "M0014839"
        ],
        "pharm_class_epc": [
          "Nicotinic Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Nicotinic Acids [CS]"
        ],
        "unii": [
          "2679MF687A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93820",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0270-2024",
      "product_description": "Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.",
      "product_quantity": "15,768 bottles",
      "reason_for_recall": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
      "recall_initiation_date": "20240118",
      "center_classification_date": "20240125",
      "report_date": "20240131",
      "code_info": "Lot #s: DNE0771A Exp. 06/30/2025; DNE0857A, DNE0959A Exp. 07/31/2025."
    }
  ]
}