{
  "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": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208915"
        ],
        "brand_name": [
          "CINACALCET"
        ],
        "generic_name": [
          "CINACALCET"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-410",
          "69097-411",
          "69097-412"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CINACALCET HYDROCHLORIDE"
        ],
        "rxcui": [
          "432400",
          "432401",
          "432402"
        ],
        "spl_id": [
          "383a7dc8-b195-4868-8774-f16a5558771e"
        ],
        "spl_set_id": [
          "02b8c11b-99e8-4039-b6fa-a9c38d2f48fa"
        ],
        "package_ndc": [
          "69097-410-02",
          "69097-411-02",
          "69097-412-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K860WSG25"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97974",
      "recalling_firm": "Cipla USA, Inc.",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0225-2026",
      "product_description": "Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.  NDC: 69097-411-02",
      "product_quantity": "15,744 bottles",
      "reason_for_recall": "CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.",
      "recall_initiation_date": "20251114",
      "center_classification_date": "20251209",
      "report_date": "20251217",
      "code_info": "Lot 5PB0164, exp 1/31/2027",
      "more_code_info": ""
    }
  ]
}