{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208368"
        ],
        "brand_name": [
          "CINACALCET"
        ],
        "generic_name": [
          "CINACALCET"
        ],
        "manufacturer_name": [
          "Dr. Reddys Laboratories Inc"
        ],
        "product_ndc": [
          "43598-367",
          "43598-368",
          "43598-369"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CINACALCET HYDROCHLORIDE"
        ],
        "rxcui": [
          "432400",
          "432401",
          "432402"
        ],
        "spl_id": [
          "b6dbd55a-a71d-0cf8-2c73-7ebbfc032906"
        ],
        "spl_set_id": [
          "0837aabc-e796-0e07-8958-71f1ff6e89bf"
        ],
        "package_ndc": [
          "43598-367-30",
          "43598-367-05",
          "43598-368-30",
          "43598-368-05",
          "43598-369-30",
          "43598-369-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343598369303"
        ],
        "unii": [
          "1K860WSG25"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95500",
      "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": "USA Nationwide.",
      "recall_number": "D-0026-2025",
      "product_description": "Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.",
      "product_quantity": "285126 bottles",
      "reason_for_recall": "CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit",
      "recall_initiation_date": "20241009",
      "center_classification_date": "20241028",
      "report_date": "20241106",
      "code_info": "Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025  Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026  Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026  Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 11/2026",
      "more_code_info": ""
    }
  ]
}