{
  "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": [
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        "substance_name": [
          "CINACALCET HYDROCHLORIDE"
        ],
        "rxcui": [
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          "432401",
          "432402"
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        "spl_id": [
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        "spl_set_id": [
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        "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-0027-2025",
      "product_description": "Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.",
      "product_quantity": "35880 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# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.",
      "more_code_info": ""
    }
  ]
}